דרושים Fellow Regulatory Affairs ב-Boston Scientific ב-ארהב

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.

About the role:

Boston Scientific is looking for a Fellow Electrical Engineer. You will be responsible for providing electrical and electronic engineering support and expertise in the definition, design, development and test of products in accordance with the Quality system standards, Design Controls and customer requirements. Ensures products are designed to facilitate manufacturability.

Your responsibilities will include:

• May work with R&D leadership to define technical roadmaps aligned with business objectives.
• Drive continuous improvement in engineering processes and methodologies.
• Collaborate with Regulatory Affairs, Clinical, Quality and Manufacturing teams etc. throughout product lifecycle.
• Participate in executive reviews and strategic planning sessions.
• Maintains substantial knowledge of state-of-the-art principles and theories in their particular area of expertise.
• Provides critical design and technical problem resolution.
• Assume technical lead in the design, development, and testing of complex bioelectronic systems comprised of PCB design, stimulation, power management, wireless communication, and sensing technologies, etc.
• May lead projects or project teams with moderate resource requirements, risk, and/or complexity.
• Can work independently within functional / divisional policies while maintaining good communication with functional and cross-functional teams.
• May help with technical recruitment, training, and ongoing support of staff.
• Provides technical guidance, training and mentorship to less senior staff contributing to their ongoing development within the company.
• Provides feedback to the development staff on customer specific enhancements as well as new applications for base product in accordance with Quality System requirements.
• Ensures new products or product enhancements are designed to facilitate transfer to manufacturing in a timely fashion and in accordance with Quality System requirements. Facilitates the process of transferring products from development to manufacturing.
• Ensures that engineering testing and documentation is in accordance with regulatory requirements for approval of products by the regulatory agencies of the countries into which the products will be marketed.
• Works with patent attorneys in documenting innovative ideas, reviewing patent application, and supporting Freedom to Operate Analysis.
• Converts complex information to compelling business context and advice.
• Presents convincing arguments for complex ideas and projects at cross-functional meetings in a way that persuades others to agree on recommendation and/or approach, when appropriate.

Required qualification:

• Bachelor’s degree in engineering or related discipline or equivalent experience. Master’s degree or higher in engineering is preferred.
• 10+ years’ experience in medical device design or similar products.
• Experience working under and knowledge of quality systems designed to meet FDA/EU regulatory requirements.
• Experience and knowledge of pre-clinical testing of medical products.
• Ability to travel 20% of the time.

Preferred qualifications:

• Demonstrates strong proficiency in Electrical Engineering, especially in analog circuit design.
• Ability to adapt and learn quickly leveraging knowledge towards the contribution of projects.
• Ability to use Microsoft Office tools for documentation, analyzing data, presenting data or ideas, etc.
• Ability to use Microsoft Excel and other data analysis tools to manipulate and analyze data sets.
• Competence in the use of Electronics CAD software (Altium) for schematic capture and PCB layout is preferred.
• Professional, clear verbal and written communications skills required.
• Ability to work independently or in a team setting as required.

Maximum Salary: $ 243000

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.

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.

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.

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.

Your responsibilities will include:

• Create/maintain accurate data entry into the complaint management system for inspected returned product.
• Returned product decontamination and route products to Complaint Investigation Site (CIS) labs.
• Review and process returned paperwork.
• Returned product retention including physical archival, maintaining accurate archive records, and product scrap.
• Respond to internal and external customer queries concerning product location, credit, or special needs or procedure changes relating to product processing.
• Understand and adhere to general safety practices, departmental process requirements and the Boston Scientific Corporation Quality Policy.
• May be responsible for SAP transactions and correct SAP error log reports.
• May perform routine laboratory testing in accordance with established procedures for returned products. Document analysis findings into complaint management system.
• Actively interface with other Boston Scientific departments to corroborate special needs or procedure changes for product processing.
• Participate in continuous improvement activities.

Required qualifications:

• 3 years of experience with a High School Degree or an equivalent combination of education/work experience

Preferred qualifications:

• 1 year of relevant experience (data entry, shipping/receiving, decontamination, or other post-market experience)
• Degree in engineering or a science-related field

Maximum Salary: $ 71552

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.

Your Responsibilities Include:

• Works with the corresponding functional and project managers to define project scope, strategy, timeline and budget associated.
• Estimates project levels of effort and resource requirements by using standard estimating techniques and tools, and by working with appropriate staff to understand scope of effort.
• Prepares project plans, schedules and budgets by using project management tools such as Microsoft Project and by working with appropriate staff to understand tasks necessary to complete project.
• Directs project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans.
• Assures project quality by using standard development methodologies and by working with the corresponding Quality representatives to develop and execute project quality plans.
• Communicates project status by preparing standard status reports, and by participating in departmental and customer project status update meetings.Resolves project issues by working with team members, project customers, and others as appropriate.
• Monitors and controls projects deliverables, and assures projects success through monitoring activities verifying activities completion and effectiveness.
• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

What We’re Looking For:

• Licenciature degree in Business Administration, Engineering or related.
• English Level: C1:(90-94%).
• Desired knowledge: certificacions (PMP, SCRUM, PgPM, PMI-ACP, PMI-RMP, PMI-SP), MS Office, MS Project, Planning, Execution, Problem Solving, Triple Constraint Management, Risk Management, Capex Management.
• At least 7 years of experience in similar position.