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דרושים Regulatory Affairs Intern ב-Boston Scientific ב-ארהב

מצאו את ההתאמה המושלמת עבורכם עם אקספוינט! חפשו הזדמנויות עבודה בתור Regulatory Affairs Intern ב-United States והצטרפו לרשת החברות המובילות בתעשיית ההייטק, כמו Boston Scientific. הירשמו עכשיו ומצאו את עבודת החלומות שלך עם אקספוינט!
חברה (1)
אופי המשרה
קטגוריות תפקיד
שם תפקיד (1)
United States
אזור
עיר
נמצאו 100 משרות
23.11.2025
BS

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...
תיאור:


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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23.11.2025
BS

Boston Scientific AIS R&D Engineer Intern - Mat Sci United States, Minnesota

Limitless High-tech career opportunities - Expoint
The role is responsible for partnering with Commercial Site OSMs (Office Service Managers), Country Coordinators (CCs) and Employee/Customer Experience Leads for the support and implementation of the facility strategy, including...
תיאור:

Thailand-Bangkok; Indonesia-Jakarta; Vietnam-Ho Chi Minh

PURPOSES:

  • The role is responsible for partnering with Commercial Site OSMs (Office Service Managers), Country Coordinators (CCs) and Employee/Customer Experience Leads for the support and implementation of the facility strategy, including all aspects of real estate portfolio, facilities, environment, health and safety, capital spending and expenses for Boston Scientific in Boston Scientific’s Growth Markets including sites in India, and the ASEAN Countries (Singapore, Malaysia, Indonesia, Thailand, Vietnam, Philippines)
  • The role directly reports to the Senior Manager, APAC Regional Real Estate, EHS
  • The role is instrumental in coordinating with diverse stakeholders to support Growth Markets commercial real estate assets, supporting its business objectives, minimizing costs, and providing innovative, efficient, and safe working environments for employees.
  • Dedicated to providing facilities that adhere to our global standards and are cost-effective, safe, and valued by Growth Markets organization and employees.

Real Estate:

  • Develop and submit the Growth Markets GFMP submission and strategy.
  • Manage EH&S initiatives including environmental, health, safety, and security performance initiatives
  • Track Site Master Plans (SMP) in Growth Markets, of associated real estate and facilities projects (acquisitions, dispositions, renovations, etc.) in support of the GFMP.
  • Evaluate capacity and space utilization at each site through data analysis and communication with appropriate departments and build reports that accurately project future population which input into SMP.
  • Tracking of all site leases, ensuring leases for existing and new sites meet BSC objectives and budget and alignment with Global GREFAC for lease management.
  • Proactively address lease and contract management including but not limited to; negotiating and managing leases for owned and leased properties, ensuring compliance with lease terms, tracking lease renewals; proposing strategic lease renewals, negotiations and/or terminations.
  • Oversee real estate development, acquisition, and disposition in accordance with organizational guidelines and expectations.

Workplace Strategy

  • Leverages workplace strategy with input from other functions to promote employee productivity, well-being, and collaboration
  • Ensuring all projects are carried out in accordance with the latest BSC Global Design Guidelines
  • Leverages space utilization metrics to make informed real estate decisions
  • Responsible for VIPs associated to country projects

Capital Projects:

  • Proactively reviews Facilities capital budget including partnering with Finance to track actuals, accruals, and variances
  • Creates and manages process for cost code alignment
  • Adheres to capital request process including CERA execution
  • Develops and implements start-up and relocation plans for new facilities and directs projects and renovations of existing facilities as needed.

Facilities Operations:

  • Responsible for vendor and contract management for regionally executed projects
  • Aligns with Sr. Manager on Soft Services process and supports inputs needed from countries
  • Manages in-country “Wheel of Spend” and ensure adherence to BSC standardized costs codes and operational expense reporting
  • Act as a liaison with major service contractors, utility contacts, and outsourced vendors.
  • Sets priorities, performs forecasting, and allocates the resources needed to complete all preventative and corrective maintenance tasks.

Environment:

  • Coordinates with Sr. Manager and Global Green Team to gather all Environment related metrics (i.e. energy, fleet, etc)
  • Develops local sustainability programs including metrics and reporting
  • Establish/Manages country specific environmental compliance registers, completion of annual regulatory assessments, and creation of improvement plans for any gaps identified
  • Responsible for driving compliance and ensuring completion of any mandatory environmental reporting/programs required in the region
  • Support Green Team Initiatives

Health & Safety:

  • Facilitate the establishment of all Growth Market Health and Safety compliance registers, completion of annual regulatory assessments, and creation of improvement plans for any gaps identified.
  • Ensure adequate emergency response plans are in place at all sites and adequate training and drills are in place
  • Ensure health and safety risk assessments are completed for all office and field-based employees, programs are in please to address any high-risk findings. Assessments and action planning are to be captured in Cority.
  • Ensure regulatory/BSC required employee exposure controls and monitoring programs are in place in the countries to protect employees, such as PPE, radiation badging, bloodborne pathogen protections.
  • Ensure all health and safety regulatory reporting, such as incidents, accidents, prescribed diseases are reported to the required authorities.
  • Ensure scheduled delivery of required EHS incident reporting and metrics to Global EHS using Cority.

REQUIREMENTS:

  • Relevant experience in facilities management.
  • Relevant experience and proven results in project management and budget management
  • Demonstrated high degree of integrity, professionalism, and the ability to establish credibility
  • Ability to work independently, highly organized, and self-driven
  • Excellent MS application skills (PPTX, Excel, Word, Project, Teams)
  • Excellent communication and business in both verbal and written English.
  • Bachelor’s degree in relevant field or 8-10 years of industry experience
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משרות נוספות שיכולות לעניין אותך

23.11.2025
BS

Boston Scientific Software Development Engineer Intern United States, Massachusetts, Waltham

Limitless High-tech career opportunities - Expoint
Building and developing relationships with cardiologists, Cath lab staff, and hospital management. Supporting physicians in procedures to ensure safe and effective product use. Identifying opportunities to expand market share within...
תיאור:

Experienced Account Manager New Cardio – Netherlands


💰Salary range: €70.000 – €85.000 including commission (25%) for someone early career – see details below.
📝Please note: the role will be posted both as a senior as well as this junior/high-potential role. We will be hiringnew colleague.

Your new role

As Account Manager New Cardio, you will be responsiblefor 10 hospital accountsin the central Netherlands – a mix of university and regional hospitals. Five of these are long-term partners; the others require a more proactive “hunter” approach. You’ll collaborate closely with cardiologists and Cath lab teams, supporting them in procedures while also developing strategic commercial opportunities. Although you will take responsibility for your own territory, you won’t be on your own.

You will be joining a supportive team led by, and work alongside experienced colleagues who will help you build your expertise step by step.

Your role will include:

  • Building and developing relationships with cardiologists, Cath lab staff, and hospital management
  • Supporting physicians in procedures to ensure safe and effective product use
  • Identifying opportunities to expand market share within your accounts
  • Collaborating on tenders, contracts, and commercial projects
  • Learning from experienced colleagues while gradually growing your own responsibility

What you bring

We are looking for someone who is motivated, curious, and driven to make an impact in healthcare. Youin sales, account management, or clinical support within MedTech or pharma. If you bring,, andstrong communication skills, we will provide the tools and mentoring to help you grow into a successful Account Manager.

Additional requirements include:

  • Bachelor’s or master’s degree in life sciences, biomedical engineering, business, or a related field
  • Affinity with healthcare or MedTech, ideally with exposure to cardiology or Cath lab environments
  • Fluency in Dutch and English (mandatory)
  • Willingness to travel regularly within your region – the accounts range from The Hague to Enschede.

What’s in it for you

Every company will tell you they offer a good salary. Of course, we do that too. For someone early in their account management/sales career, the salary is
likely between €70.000 – €85.000 including 25% commission. For more experienced candidates, this can go up to €105.000 – €130.000 depending on your expertise. This includes holiday allowance and 13th month.

You will also receive a company car with European fuel card, phone, and laptop. Our company offers extensive learning opportunities, including a Talent Portal for stretch assignments. We offer 30 days of annual leave, a strong pension plan, and a €950 net contribution toward your health insurance (2025).

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משרות נוספות שיכולות לעניין אותך

23.11.2025
BS

Boston Scientific Scientific Affairs Manager Carotid United States, Minnesota

Limitless High-tech career opportunities - Expoint
Maintaining advanced clinical knowledgeof EP diagnostic and ablation technologies, PFA, mapping and recording systems, transeptal access tools, and left atrial appendage occlusion technologies I add. to provide clinical support on...
תיאור:

About the role:

Our technologies encompass 3D Mapping and Navigation systems, Radiofrequency Ablation catheters, Diagnostic Catheters, EP recording systems, and Intracardiac Access Sheaths to diagnose and treat heart rhythm disorders.

In this field-based role, the Electrophysiology Mapping Specialist will begin with an intensive training and development program to gain in-depth knowledge of our technologies and prepare for success. Upon completion, the specialist will provide expert clinical, technical, and educational support to physicians, EP Lab staff, and sales representatives during cardiac procedures using the

Your responsibilities will include:

  • Maintaining advanced clinical knowledgeof EP diagnostic and ablation technologies, PFA, mapping and recording systems, transeptal access tools, and left atrial appendage occlusion technologies I add

  • to provide clinical support on Boston Scientific AF Solutions products, including the,, transeptal access tools, diagnostic and therapeutic catheters, and

  • on clinical usage and benefits of AF Solutions products through customized presentations, demonstrations, and ongoing training

  • Meeting with physicians and clinical stakeholders

  • Developing relationshipswith hospital staff, physicians, and administrators to expand influence across departments and facilitate strategic decision-making

  • Responding to clinical and technical inquiries

  • Demonstrating change leadership

  • Implementing strategies outlined in quarterly action plans

  • Supporting physician education and market developmentby engaging referring physicians, fellows, and key opinion leaders

  • Training on and adhering to clinical trial protocols and compliance standardsin line with global regulatory expectations

  • Managing clinical trial activity within the territory, including Interest Visits and Site Initiation Visits, and educating investigators on study procedures and products

Required qualifications:

  • Bachelor’s degree or equivalent experience

  • Minimum of 2 years of industry experience in medical device sales, clinical electrophysiology, or equivalent background

  • Demonstrated technical aptitude with the ability to convey complex product details clearly

Preferred qualifications:

  • NASPE/IBHRE CEPS certification

  • Experience in atrial fibrillation, cardiac mapping, or structural heart procedures

  • Familiarity with 3D cardiac mapping systems

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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משרות נוספות שיכולות לעניין אותך

22.11.2025
BS

Boston Scientific Equipment Engineering Controls Engineer Intern United States, Minnesota

Limitless High-tech career opportunities - Expoint
Collaborate with engineers across disciplines to design, code, and test innovative applications and manufacturing equipment. Develop and maintain PLC-based hardware interfaces that are intuitive, well-documented, and production-ready. Support automation and...
תיאור:

Your responsibilities will include:

  • Collaborate with engineers across disciplines to design, code, and test innovative applications and manufacturing equipment
  • Develop and maintain PLC-based hardware interfaces that are intuitive, well-documented, and production-ready
  • Support automation and controls design for electro-mechanical systems, industrial robots, and collaborative robotics platforms
  • Assist in troubleshooting software and electrical issues on the production floor, contributing to rapid problem resolution
  • Update and maintain electrical schematics and documentation for manufacturing systems and tooling
  • Apply programming skills (e.g., ladder logic, structured text, Python, or C-based languages) to support equipment functionality and diagnostics
  • Design robust systems with long-term maintainability, scalability, and supportability in mind
  • Participate in continuous improvement initiatives focused on performance, reliability, and user experience
  • Contribute to the development and support of both legacy and emerging technologies across high-volume automation and low-volume manual assembly environments

Required Qualifications:

  • Current rising junior or rising senior (grad dates between Dec 2026 - May 2028), graduating senior (May 2026 grad) continuing on to grad school, or current grad student. Must have at least one semester of school left post-internship to qualify.
  • Pursuing a Bachelors or Masters degree in Computer Science, Computer Engineering, or Electrical Engineering
  • Must be able to start internship on May 18th or 26th, 2026 and work for 12 weeks
  • Must have reliable transportation to/from work.
  • Experience with hands-on testing, troubleshooting, or equipment development in academic or professional settings
  • Familiarity with embedded firmware and programming languages such as Python, C, C++, or C#
  • Exposure to PLC programming and hardware interface design
  • Ability to read, update, and maintain electrical schematics for manufacturing systems
  • Understanding of automation and controls design, including electro-mechanical systems and robotics

Preferred Qualifications:

  • Experience supporting the design, build, or integration of custom engineering tools or systems
  • Experience working in collaborative, Agile environments with cross-functional engineering teams
  • Strong problem-solving skills and a self-starter mindset with attention to long-term system reliability
  • Enthusiasm for continuous improvement and innovation in manufacturing processes
  • Medical industry experience
  • Ability to communicate effectively with diverse, cross-functional teams
  • Passion to learn new technologies and find new solutions

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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משרות נוספות שיכולות לעניין אותך

22.11.2025
BS

Boston Scientific Global Regulatory Compliance Senior Manager United States, Massachusetts, Marlborough

Limitless High-tech career opportunities - Expoint
Manage, coach, and develop a team of quality system auditors that execute both the Corporate audit schedule as well as a global risk-based audit schedule. Partner with Quality leaders across...
תיאור:

About the role:

The GRC Manager will work as part of a broad, global team within the Global Quality system and particularly with all site and divisional Quality leadership to identify any gaps in compliance with internal and external requirements.

The Global Regulatory Compliance Manager will create a culture of compliance and facilitate adherence to the BSC Quality System and all appropriate regulations that BSC follows. They will ensure appropriate quality system processes are created, maintained, and followed in support of Corporate and Site quality objectives.

Your responsibilities will include:

  • Manage, coach, and develop a team of quality system auditors that execute both the Corporate audit schedule as well as a global risk-based audit schedule.
  • Partner with Quality leaders across the BSC network (sites, divisions, and regions) to ensure a high level of compliance by developing and deploying a data-driven, risk-based audit schedule.
  • Support the audit team in identifying and documenting significant quality system nonconformances against external regulations and internal SOPs/WIs.
  • Act as the sub-process steward for the global Internal Audit process.
  • Lead the development and ownership of the strategic process roadmap as well as ownership of the internal audit community of practice.
  • Implement auditor training, technical tools and drive continuous improvement and efficiencies to support a preventive quality culture.
  • Review and assess changes to standards and regulations applicable to the assigned area for potential impact to BSC and initiate projects, as needed, to ensure continued compliance.
  • Facilitate external audits through leadership in audit front rooms, back rooms, training for SME’s, creation of storyboard material and site level support for Global procedures.
  • Deliver process improvements through the VIP model with year over year savings against a multimillion-dollar yearly goal.
  • Act as a CAPA owner for corrective actions necessary to improve the global processes.
  • Champion departmental or cross-functional quality initiatives.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Required qualifications:

  • Minimum of Bachelor’s degree in relevant field
  • Minimum of 10 years of Medical Device Quality Systems experience including extensive experience auditing
  • Understanding of regulations and standards applicable to the BSC Global Quality System (ISO 13485, 21 CFR 820, EU MDR, etc.).
  • Demonstrated inclusive leadership skills
  • High degree of integrity, professionalism, and the ability to establish credibility internally and externally
  • High sense of urgency and commitment to execution
  • Ability to travel up to 25 - 30% domestically and internationally

Preferred qualifications:

  • Advanced degree
  • Pharmaceutical experience
  • Digital product ownership and/or IT project experience
  • Strong analytical and communication skills

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.

Show more

משרות נוספות שיכולות לעניין אותך

22.11.2025
BS

Boston Scientific Regulatory Affairs Intern United States, Minnesota

Limitless High-tech career opportunities - Expoint
Learn regulatory requirements to commercialize medical devices. Support EU MDR Technical Documentation updates. Prepare and submit regulatory submissions (potential example - FDA PMA supplement for a manufacturing change). Use regulatory...
תיאור:

Maple Grove, MN; Arden Hills, MN

We will consider qualified applicants of all ages who are starting (or restarting) their careers

About the Role:

Interns working in Regulatory will support many of our global commercial products by working on regulatory submissions, upholding global regulatory requirements, maintaining internal regulatory file documentation and supporting continuous improvement activities.

Your Responsibilities will include:

  • Learn regulatory requirements to commercialize medical devices
  • Support EU MDR Technical Documentation updates
  • Prepare and submit regulatory submissions (potential example - FDA PMA supplement for a manufacturing change)
  • Use regulatory advocacy to influence the regulatory process
  • Collaborate with cross functional partners to support product and manufacturing changes and draft assessments regarding compliance with applicable regulations

Required Qualifications:

  • Must graduate between Fall 2026 and Spring 2027
  • Currently pursuing a degree in a Science or Healthcare related major, OR Engineering, Exercise Science, Psychology, Math, Business, English or Communications, OR a Master’s degree in Regulatory Affairs, Clinical Affairs, or Public Health
  • Must be able to commit to one of the following full internship program periods: May 18th – August 7th OR May 26th – August 14th
  • Must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization
  • Must have reliable transportation to and from the Maple Grove, MN or Arden Hills, MN Boston Scientific Corporate location
  • Experience with Office Suite: PowerPoint, Word, Excel, Outlook
  • Prior experience with owning and executing a project with a direct output (study or experiment)

Preferred Qualifications:

  • Technical writing experience
  • Experience in medical device or healthcare field, in a school or professional environment
  • Must possess excellent written and verbal communication skills
  • Display basic understanding of data collection, analysis and interpretation tools, techniques and outcomes
  • Confident presentation skills preferred
  • Ability to translate technical information into clearly written documents
  • Quick learner, self-motivated, independent worker

Maximum Salary: $97,760

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.

Show more

משרות נוספות שיכולות לעניין אותך

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...
תיאור:


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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בואו למצוא את עבודת החלומות שלכם בהייטק עם אקספוינט. באמצעות הפלטפורמה שלנו תוכל לחפש בקלות הזדמנויות Regulatory Affairs Intern בחברת Boston Scientific ב-United States. בין אם אתם מחפשים אתגר חדש ובין אם אתם רוצים לעבוד עם ארגון ספציפי בתפקיד מסוים, Expoint מקלה על מציאת התאמת העבודה המושלמת עבורכם. התחברו לחברות מובילות באזור שלכם עוד היום וקדמו את קריירת ההייטק שלכם! הירשמו היום ועשו את הצעד הבא במסע הקריירה שלכם בעזרת אקספוינט.