Boston Scientific Gruppe
Regulatory Affairs Specialist III
Boston Scientific Gruppe, Arden Hills, Minnesota, United States
Overview
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling important health industry challenges. You’ll have access to the latest tools, information and training to help advance your skills and career, with support in progressing toward your ambitions.
About the role This position plays a critical role in advancing Boston Scientific’s groundbreaking Atrial Fibrillation technology—the FARAPULSE Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System was the first PFA technology to receive CE Mark approval in Europe and represents a transformative innovation with the potential to shape the future of ablation therapy worldwide.
Role focus Regulatory Affairs Specialist III
will plan, manage, and implement regulatory submissions to the US FDA, EU notified bodies, and support worldwide product registrations. You will ensure ongoing compliance with regulatory approvals, including leading change impact reviews, while partnering with cross-functional teams to bring innovative therapies to patients around the globe.
Work model, sponsorship, relocation This role follows a hybrid work model requiring employees to be in the local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Your responsibilities
Support the development of domestic and international strategies for regulatory approval of Class I, II, and III medical devices.
Represent Regulatory Affairs on cross-functional projects, including product development, manufacturing process changes, and continuous improvement efforts.
Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations.
Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, 510(k)s, Annual Reports, and CE Mark submissions under MDR.
Support international regions to gain and maintain product approvals.
Contribute to continuous improvement of departmental and divisional quality through collaboration, best practices, and knowledge sharing.
Support regulatory audits, as required.
Qualifications Required qualifications:
Minimum of 3 years' experience in Regulatory Affairs or a related discipline within medical devices (R&D, Quality, Clinical, Biocompatibility, Labeling).
Demonstrated experience authoring and supporting a variety of regulatory submissions for US and EU, such as PMA Supplements, pre-submissions, 510(k)s, Annual Reports, and CE Mark submissions under MDR.
Proficiency with submission and presentation-related computer skills, including Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.
Preferred qualifications:
Previous experience in the medical device industry with Class II or III device submissions.
General understanding of the product development process and design controls.
Working knowledge of FDA, EU, and international regulations.
Ability to thrive in fast-paced, cross-functional team environments.
Strong project management skills, with the ability to manage multiple priorities.
Effective research and analytical skills.
Strong written and oral communication, technical writing, and editing skills.
Experience with Boston Scientific capital equipment and/or single-use sterilized devices.
Compensation and related information
Requisition ID:
615058
Minimum Salary:
76,000 USD
Maximum Salary:
144,400 USD
The anticipated compensation and benefits vary by location and experience. Compensation will be commensurate with demonstrable experience and training, including licensure and certifications. This employer states it is not typical to hire near the bottom or top of the salary range.
Compensation for non-exempt (hourly), non-sales roles may include variable compensation and annual bonus targets. For exempt, non-sales roles, variable compensation, including annual bonuses and long-term incentives, may apply.
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.
Additional information Boston Scientific is committed to solving challenges that matter most and to advancing science for life. We value diversity and inclusion, and we are an equal opportunity employer. We comply with applicable state and federal laws regarding COVID-19 vaccination requirements where required by law and policy.
Nearest Major Market: Minneapolis
Job Segment: Regulatory Affairs, Medical Device, Compliance, Technical Writer, Law, Legal, Healthcare, Technology
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About the role This position plays a critical role in advancing Boston Scientific’s groundbreaking Atrial Fibrillation technology—the FARAPULSE Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System was the first PFA technology to receive CE Mark approval in Europe and represents a transformative innovation with the potential to shape the future of ablation therapy worldwide.
Role focus Regulatory Affairs Specialist III
will plan, manage, and implement regulatory submissions to the US FDA, EU notified bodies, and support worldwide product registrations. You will ensure ongoing compliance with regulatory approvals, including leading change impact reviews, while partnering with cross-functional teams to bring innovative therapies to patients around the globe.
Work model, sponsorship, relocation This role follows a hybrid work model requiring employees to be in the local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Your responsibilities
Support the development of domestic and international strategies for regulatory approval of Class I, II, and III medical devices.
Represent Regulatory Affairs on cross-functional projects, including product development, manufacturing process changes, and continuous improvement efforts.
Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations.
Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, 510(k)s, Annual Reports, and CE Mark submissions under MDR.
Support international regions to gain and maintain product approvals.
Contribute to continuous improvement of departmental and divisional quality through collaboration, best practices, and knowledge sharing.
Support regulatory audits, as required.
Qualifications Required qualifications:
Minimum of 3 years' experience in Regulatory Affairs or a related discipline within medical devices (R&D, Quality, Clinical, Biocompatibility, Labeling).
Demonstrated experience authoring and supporting a variety of regulatory submissions for US and EU, such as PMA Supplements, pre-submissions, 510(k)s, Annual Reports, and CE Mark submissions under MDR.
Proficiency with submission and presentation-related computer skills, including Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.
Preferred qualifications:
Previous experience in the medical device industry with Class II or III device submissions.
General understanding of the product development process and design controls.
Working knowledge of FDA, EU, and international regulations.
Ability to thrive in fast-paced, cross-functional team environments.
Strong project management skills, with the ability to manage multiple priorities.
Effective research and analytical skills.
Strong written and oral communication, technical writing, and editing skills.
Experience with Boston Scientific capital equipment and/or single-use sterilized devices.
Compensation and related information
Requisition ID:
615058
Minimum Salary:
76,000 USD
Maximum Salary:
144,400 USD
The anticipated compensation and benefits vary by location and experience. Compensation will be commensurate with demonstrable experience and training, including licensure and certifications. This employer states it is not typical to hire near the bottom or top of the salary range.
Compensation for non-exempt (hourly), non-sales roles may include variable compensation and annual bonus targets. For exempt, non-sales roles, variable compensation, including annual bonuses and long-term incentives, may apply.
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.
Additional information Boston Scientific is committed to solving challenges that matter most and to advancing science for life. We value diversity and inclusion, and we are an equal opportunity employer. We comply with applicable state and federal laws regarding COVID-19 vaccination requirements where required by law and policy.
Nearest Major Market: Minneapolis
Job Segment: Regulatory Affairs, Medical Device, Compliance, Technical Writer, Law, Legal, Healthcare, Technology
#J-18808-Ljbffr