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West Pharma Senior Regulatory Affairs Specialist United States, Pennsylvania, West Whiteland Township

Limitless High-tech career opportunities - Expoint
Develop and implement medical device regulatory strategies for West’s administration and safety system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant...
Description:

Job Summary

The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, China NMPA Registrations, Technical Documentation for CE Marking, and technical packages. The Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables.  In addition, the Sr. Specialist mentors team members and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This position includes supporting internal and external customer regulatory requests.

Essential Duties and Responsibilities
  • Develop and implement medical device regulatory strategies for West’s administration and safety system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner.
  • Author and review US, EU, and additional international submissions with guidance for new products and product changes as required to ensure content accuracy, compliance with applicable regulations, and timely approvals for market release.
  • Provide technical review of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
  • Provide leadership to cross functional teams for regulatory issues and questions.
  • Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products.
  • Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.
  • Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to RA management, internal and external customers.
  • Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals
  • Adhere to all applicable government and West regulations, practices, and procedures to maintain compliance
  • Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required
Education
  • Bachelor’s degree or equivalent experience is required
  • Master’s degree or PhD in science, math, engineering, or related discipline preferred
Work Experience
  • Minimum 5 years of relevant experience
  • 2+ years of medical device regulatory experience preferred
  • Experience with US FDA regulations (Title 21CFR820), EU MDD (93/42/EEC) and EU MDR (2017/745)
  • History of successful international device registration,EU MDR technical documentation and/or US 510(K) authoring experience
  • Advanced knowledge of ISO 13485
  • Advanced knowledge of product life cycle, product development process, design control and change control
  • Experience interacting with government agencies
  • Excellent oral communication, technical writing, and decision-making skills
Preferred Knowledge, Skills and Abilities
  • Attention to detail with planning, time management and organizational skills
  • Regulatory compliance competency including Quality Systems
  • Experience with administration and safety systems preferred
  • Ability to triage and manage work priorities and to follow established processes while identifying areas for process improvement.
Additional Requirements
  • Ability to comprehend principles of math, science, engineering, and medical device use.
  • Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
  • Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
  • Ability to review, collate, describe, and summarize scientific and technical data.
  • Ability to organize complex information and combine pieces of information to form general rules or conclusions.
  • Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
  • Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
  • Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams.
  • Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures.
  • Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment.
  • Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.
  • Ability to verbally communicate ideas and issues effectively to other team members and management.
  • Ability to write and record data and information as required by procedures.
  • Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).
License and Certifications
  • Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
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Boston Scientific Senior Meeting Planning Specialist United States, Minnesota

Limitless High-tech career opportunities - Expoint
Manage program logistics including sleeping rooms, flights, food and beverage, ground transportation, meeting room set-up, budgets, attendee management, communications, and onsite materials. Build and manage event registration processes using Cvent,...
Description:

About the role:

This position is responsible for the strategic planning and execution of PI Vascular Medical Affairs and Professional Education meetings.

Your responsibilities will include:

  • Manage program logistics including sleeping rooms, flights, food and beverage, ground transportation, meeting room set-up, budgets, attendee management, communications, and onsite materials.
  • Build and manage event registration processes using Cvent, ensuring accurate data management, providing attendee support, generating reports, and collaborating with cross-functional teams for seamless event execution.
  • Manage surveys and evaluate feedback from the training programs and working closely with the Program Mangers to make changes to our current programs to ensure use of both best practice and new innovative education methods.
  • Ensures consistency and collaboration for meetings while following established guidelines, processes, and tools.
  • Defines, tracks, and maintains budgets while ensuring cost-saving measures and spending are within allocated amounts.
  • Maintains and enhances knowledge of the meetings & events industry trends and best-in-class practices.
  • Partners with and manages vendors to ensure objectives are being met.
  • Runs reports and presents data metrics to leadership for all Medical Affairs & Ed as requested.
  • Planning and coordinating other projects that contribute to the accomplishment of the clinical education goals and objectives
  • Communicates proactively to stakeholders across all levels of the organization.
  • Educates cross-functional teams, provides direction, and establishes solutions where appropriate.
  • Ensures all company policies and compliance practices are being followed.

Required qualifications:

  • Bachelor’s degree or equivalent
  • A minimum of 5 years of related experience in event/meeting planning
  • Proven history of working on international HCP programs and outside of the US compliance policies.
  • Candidate must have appetite for innovation and continuous learning.
  • Ability to develop and maintain relationships with physician customers and sales teams.
  • Works independently on complex meetings
  • Must be a strong communicator and collaborator
  • Ability to develop new processes and adjust practices to meet business needs.
  • Strong organizational and multitasking skills with meticulous attention to detail.
  • Ability to handle high volume workload and fast pace; manage stress
  • Strong project management and organization skills; detail-oriented
  • Proficient in the use of Microsoft Office Suite, Cvent and SalesForce.com
  • Domestic travel required up to 20%
  • Ability to lift 20lbs
  • Ability to work extended hours/weekend hours, as needed

Preferred qualifications:

  • Experience in the medical device industry

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).


For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

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Boston Scientific Senior Regulatory Affairs Specialist - Endoscopy United States, Massachusetts, Marlborough

Limitless High-tech career opportunities - Expoint
Develop and implement regulatory strategies for new and modified medical devices. Serve as a core team member on development projects, providing regulatory input throughout the product development lifecycle. Draft and...
Description:


At Boston Scientific, you’ll find purpose through your life’s work—improving lives with innovative medical solutions. Within our, we develop and deliver advanced technologies that diagnose and treat diseases of the digestive system, airway, and lungs. Our portfolio includes solutions in

We continue to invest in innovation across both established platforms and new pipeline development. As a, you will play a key role in supporting the global regulatory strategy for our Endoscopy product lines—from new product introductions to sustaining and post-market activities.


• Develop and implement regulatory strategies for new and modified medical devices
• Serve as a core team member on development projects, providing regulatory input throughout the product development lifecycle
• Draft and submit U.S. and EU regulatory filings for new and modified medical devices
• Review device labeling and advertising materials to ensure regulatory compliance and alignment with submission claims
• Review change notifications and conduct regulatory impact assessments for product and manufacturing changes
• Support associated global submissions in accordance with applicable regulations
• Serve as company representative in communications with regulatory agencies regarding submission strategy, testing requirements, and clarification or follow-up during review
• Support and maintain Boston Scientific's Quality initiatives in accordance with our Quality Policy
• Continuously identify and support opportunities for quality improvement across the organization


• Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline
•in Regulatory Affairs within the medical device industry
• Strong working knowledge of
• General understanding of
• Familiarity with regulations related to the conduct of clinical trials
• Ability to manage multiple regulatory projects simultaneously


• Experience preparing and submitting, or international registrations
• Proficiency with Microsoft Office tools
• Strong analytical, research, and problem-solving skills
• Excellent written and oral communication, technical writing, and editing abilities
• Demonstrated ability to work independently with minimal supervision

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).


For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

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Boston Scientific AF Solutions Clinical Specialist II - Wichita KS United States, Kansas, Wichita

Limitless High-tech career opportunities - Expoint
andthrough compelling presentations, hands-on training, and clinical support. Traveling regularly to hospitals and clinics to assess customer needs, deliver procedural support, and guide physicians on best practices for patient care....
Description:


Your responsibilities will include:

  • andthrough compelling presentations, hands-on training, and clinical support

  • Traveling regularly to hospitals and clinics to assess customer needs, deliver procedural support, and guide physicians on best practices for patient care

  • Building strong relationships with clinical and administrative stakeholders to identify opportunities for therapy adoption and market expansion

  • Collaborating across cross-functional teams—sales, marketing, clinical research, and training—to deliver strategic insights and implement territory-specific plans

  • Championing new product launches and acting as a resource for competitive intelligence within the electrophysiology and structural heart space

  • Supporting market development initiatives by connecting with key opinion leaders, external fellows, and referring physicians to promote awareness and utilization

  • Contributing to talent development and mentoring new team members as needed, while embracing Boston Scientific’s inclusive and high-performance culture

  • Monitoring clinical trial activity in your area, including interest visits, site initiations, and protocol education

  • Ensuring compliance with regulatory requirements and internal procedures by maintaining current knowledge of clinical trial protocols and standards

  • Participating in on-call coverage as required to support critical case needs

Required qualifications:

  • Minimum of a bachelor’s degree or equivalent experience.

  • Minimum of 2 years' experience in clinical cardiology, medical device sales, or a related industry.

Preferred qualifications:

  • Experience in structural heart, atrial fibrillation, or electrophysiology strongly preferred.

  • Demonstrated technical aptitude with the ability to communicate complex clinical and product information effectively.

  • Advanced degree in healthcare or business is a plus.

The anticipated annualized base amount or range for this full time position will be, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.


For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

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Boston Scientific Clinical Specialist Interventional Solutions - Phoenix AZ United States, Arizona, Phoenix

Limitless High-tech career opportunities - Expoint
Assist in execution of proactive regional plan that involves clinical, sales, and service support to improve market share and increase quality of service to customers. Serves as primary resource for...
Description:

Your responsibilities will include:

  • Assist in execution of proactive regional plan that involves clinical, sales, and service support to improve market share and increase quality of service to customers.
  • Serves as primary resource for clinical support in the areas of case coverage, basic troubleshooting, specialty product usage and customer training.
  • Attends cases in customer accounts and advises physicians on clinical attributes / techniques associated with our coronary products. Represents Interventional Solutions field organization during designated BSC clinic lab days.
  • Educates customers on the merits and proper clinical usage of company products by giving presentations and demonstrations using a wide variety of formats and platforms. Provide supplemental training support during product launches and for high touch specialty products (filter wire /rotablator).
  • Responds to customer needs and complaints regarding products and service by developing creative and feasible solutions or working with other related personnel to develop optimal solutions (especially training, troubleshooting and general case support for iLab hardware / IVUS).
  • Responsible for consignment inventory tracking, semiannual audits, expired product and returns.
  • Ensure timely collection, reporting of all required medical documentation pertaining to our procedural device operation.
  • Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements.
  • Must live within the assigned geographical territory.

Required qualifications

  • BA/BS required or equivalent work experience.
  • Minimum of 2 years of relevant experience in sales, healthcare industry, or clinical setting.
  • Must have a technical aptitude; be able to discuss & explain complex technical product information.
  • Must be able to work flexible hours and travel when needed.
  • Strong business acumen and strategic problem-solving skills.
  • Ability to interact effectively with internal and external customers (including all BSC divisions).

Preferred qualifications

  • Clinical work experience in Cardiology within the medical device and/or pharmaceutical industry (clinical, sales).
  • Prior experience supporting interventional cardiology procedures in a catheterization lab or hybrid OR environment
  • Demonstrated success in a customer-facing field role within a medical device company, with a focus on cardiovascular or interventional solutions
  • Familiarity with intravascular imaging technologies (e.g., IVUS, iLab) and atherectomy systems (e.g., Rotablator)
  • Strong presentation and training skills, with experience delivering product education to physicians, nurses, and lab staff

The anticipated annualized base amount or range for this full time position will be$65,000 to $85,000, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.


For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

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Boston Scientific AF Solutions Clinical Specialist II - Phoenix AZ United States, Arizona, Phoenix

Limitless High-tech career opportunities - Expoint
Produce high quality products, safely, on time for the customer at the lowest cost. Facilitate and partner with a cross functional production team of production, quality and manufacturing engineering team...
Description:

Your Responsibilities will Include:

  • Produce high quality products, safely, on time for the customer at the lowest cost
  • Facilitate and partner with a cross functional production team of production, quality and manufacturing engineering team members to achieve annual safety, quality, service and cost goals while maintaining a high engagement & high-performance culture
  • Identify customer requirements to deliver the right products at the right time
  • Be responsive & flexible to customer demands
  • Achieve & exceed product cost goals
  • Support new product development readiness activities for the line team
  • Manufacture products to the highest quality standards and ensure compliance to all Boston Scientific policies and regulations
  • Promote safety, quality & compliance among the team while maintaining Good Manufacturing Practices
  • Foster teamwork and enable a culture of Operational Excellence throughout the entire cross-functional team
  • Ensure effective two-way communication between the production line team and cross-functional support teams
  • Manage, motivate, develop, and involve product builders through coaching and performance management
  • Embed the company values through demonstration & recognition of individual & team behaviors
  • Utilize production area planning tools to ensure all resources are in place to achieve team commitments such as Direct Labor Staffing, Equipment Capacity, Support Team, and Space
  • Ensure product builder training is effective & efficient and maintain training versatility across entire team
  • Utilize leader standard work to ensure lines are meeting standards and escalate appropriately
  • Lead & create team engagement around continuous improvement goals for safety, quality, service, cost and space through the utilization of lean and operational excellence tools and best practices
  • Benchmark and share best practices
  • Partner with materials management team for build planning and material delivery systems and tools
  • Analyze build plan requirements and provide forward looking monthly production commitments
  • Anticipate requirements and position resources to meet & exceed the customer needs
  • Provide appropriate input into the long-term planning of the production area


Required Qualifications:

  • Bachelor’s Degree or equivalent combination of education and experience will be considered in lieu of degree
  • Manufacturing or engineering experience
  • Solid computer skills required including Microsoft Excel, Word, and PowerPoint
  • Demonstrated Lean tools/systems experience
  • Able to support and lead a production team working 2nd shift hours (1:30 PM – 9:30 PM), Monday through Friday.

Preferred Qualifications:

  • 3+ years of supervisor/management experience
  • Experience in a regulated environment
  • Medical device industry experience
  • Strong written and verbal communication skills with the ability to communicate at all levels of the organization
  • Ability to be flexible and agile
  • Ability to be a self-starter

Maximum Salary: $ 132000

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).


For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

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Boston Scientific Senior EH & Specialist United States, California, Carlsbad

Limitless High-tech career opportunities - Expoint
Develop, implement, and maintain EH&S policies and procedures in compliance with federal, state, and local regulations. Conduct risk assessments, inspections, and performance analyses to identify hazards and implement corrective actions....
Description:

About the role:

Boston Scientific is seeking a highly experienced and proactiveto lead environmental, health, and safety initiatives across manufacturing and R&D operations. This critical role ensures compliance with regulatory requirements, mitigates workplace risks, and champions a culture of safety, sustainability, and continuous improvement.

Your responsibilities will include:

● Develop, implement, and maintain EH&S policies and procedures in compliance with federal, state, and local regulations.

● Conduct risk assessments, inspections, and performance analyses to identify hazards and implement corrective actions.

● Lead incident investigations and root cause analyses; ensure timely resolution and documentation.

● Deliver training on hazardous materials handling, emergency response, industrial hygiene, laser safety, and general workplace safety.

● Evaluate work-related injuries and incidents in alignment with applicable laws and internal protocols.

● Manage hazardous waste and chemical handling operations to maintain compliance and safety.

● Collaborate with engineering, facilities, and operations teams to embed EH&S into process improvements.

● Mitigate ergonomic risks across manufacturing and office environments through proactive assessments, workstation design, training, and best practices.

● Maintain and enhance the laser safety program through site-specific protocols, risk assessments, and comprehensive training.

● Serve as a liaison with fire, police, and HAZMAT agencies to support emergency preparedness and response planning.

● Support onboarding and ongoing safety education programs.

● Coordinate Emergency Response Team activities and ensure overall site readiness.

● Chair or contribute to EH&S-related committees, task forces, or cross-functional teams.

● Represent EH&S in cross-functional projects such as new chemical introductions, equipment implementations, and facility changes.

● Maintain and report site EH&S metrics and statistics to ensure regulatory and corporate compliance.

● Act as the facility’s Hazardous Materials/Waste Coordinator, including oversight of all regulated and non-regulated waste streams and vendor management.

● Provide regulatory guidance for equipment specifications, installations, and facility modifications.

● Conduct internal and external EH&S compliance audits, self-assessments, and inspections.

● Partner with Supervisors, Trainers, and Technicians to identify and control environmental health and safety risks across operations.

Required qualifications:

● Bachelor’s degree in Environmental and Occupational Health, Occupational Safety, Safety Engineering, or Safety Management. Equivalent experience may be considered in lieu of a degree.

● Minimum of 5 years' experience in progressive EH&S roles.

● Demonstrated experience in medical device, biotech, or advanced manufacturing environments.

● Strong knowledge of relevant regulatory frameworks and compliance standards.

● Proven ability to influence, lead, and coach across multiple departments.

● Effective communicator with strong problem-solving and leadership skills.

● Experience leading ergonomic and injury prevention initiatives, including risk assessments and root cause analysis.

● Ability to develop and deliver EH&S training programs to diverse audiences.

Preferred qualifications:

● 7 or more years' experience managing EH&S programs with site-wide impact.

● Familiarity with EH&S metrics reporting, incident tracking systems, and internal audit programs.

Maximum Salary: $ 164500

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).


For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

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Limitless High-tech career opportunities - Expoint
Develop and implement medical device regulatory strategies for West’s administration and safety system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant...
Description:

Job Summary

The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, China NMPA Registrations, Technical Documentation for CE Marking, and technical packages. The Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables.  In addition, the Sr. Specialist mentors team members and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This position includes supporting internal and external customer regulatory requests.

Essential Duties and Responsibilities
  • Develop and implement medical device regulatory strategies for West’s administration and safety system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner.
  • Author and review US, EU, and additional international submissions with guidance for new products and product changes as required to ensure content accuracy, compliance with applicable regulations, and timely approvals for market release.
  • Provide technical review of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
  • Provide leadership to cross functional teams for regulatory issues and questions.
  • Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products.
  • Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.
  • Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to RA management, internal and external customers.
  • Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals
  • Adhere to all applicable government and West regulations, practices, and procedures to maintain compliance
  • Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required
Education
  • Bachelor’s degree or equivalent experience is required
  • Master’s degree or PhD in science, math, engineering, or related discipline preferred
Work Experience
  • Minimum 5 years of relevant experience
  • 2+ years of medical device regulatory experience preferred
  • Experience with US FDA regulations (Title 21CFR820), EU MDD (93/42/EEC) and EU MDR (2017/745)
  • History of successful international device registration,EU MDR technical documentation and/or US 510(K) authoring experience
  • Advanced knowledge of ISO 13485
  • Advanced knowledge of product life cycle, product development process, design control and change control
  • Experience interacting with government agencies
  • Excellent oral communication, technical writing, and decision-making skills
Preferred Knowledge, Skills and Abilities
  • Attention to detail with planning, time management and organizational skills
  • Regulatory compliance competency including Quality Systems
  • Experience with administration and safety systems preferred
  • Ability to triage and manage work priorities and to follow established processes while identifying areas for process improvement.
Additional Requirements
  • Ability to comprehend principles of math, science, engineering, and medical device use.
  • Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
  • Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
  • Ability to review, collate, describe, and summarize scientific and technical data.
  • Ability to organize complex information and combine pieces of information to form general rules or conclusions.
  • Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
  • Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
  • Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams.
  • Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures.
  • Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment.
  • Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.
  • Ability to verbally communicate ideas and issues effectively to other team members and management.
  • Ability to write and record data and information as required by procedures.
  • Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).
License and Certifications
  • Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
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Are you interested in looking at data across various industries? Do you have an eye for detail and an ability to identify and accurately process information? Are you a tech-savvy problem solver? If so, Expoint has the perfect opportunity for you! As a Data Entry Specialist at Expoint, you will be responsible for the accurate and timely entry of data into our platform and other related software systems. This role requires attention to detail and an ability to understand complex patterns and trends in data. You will work personally with our different teams of developers, engineers, analysts and data scientists, using your technical skills to manage, enter and update data. Your main responsibilities will include front-end data entry, reviewing and verifying data accuracy, troubleshooting errors, maintaining and monitoring the accuracy of entries, producing feedback reports, and cross-checking data integrity agendas. You should also be familiar with principles and industry best practices in data entry and transforming data into meaningful insights. Plus, you will be working in an innovative, cutting-edge environment where your talents and dedication will be recognized and rewarded. By joining Expoint, you will bring valuable data entry experience to our platform and build a long lasting career in the tech industry. So, if you are tech-savvy, highly organized and have a passion for data, Expoint is the place for you!