Boston Scientific Gruppe
Regulatory Affairs Specialist III
Boston Scientific Gruppe, Arden Hills, Minnesota, United States
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
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.
As a Regulatory Affairs Specialist III, you will plan, manage, and implement regulatory submissions to the US FDA, EU notified bodies, and support worldwide product registrations. You will also ensure ongoing compliance with regulatory agency 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: At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our 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 will include:
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.
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.
Requisition ID: 615058
Minimum Salary: $76000
Maximum Salary: $144400
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.
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.
Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
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.
Nearest Major Market:
Minneapolis Job Segment:
Regulatory Affairs, Medical Device, Compliance, Technical Writer, Law, Legal, Healthcare, Technology
#J-18808-Ljbffr
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.
As a Regulatory Affairs Specialist III, you will plan, manage, and implement regulatory submissions to the US FDA, EU notified bodies, and support worldwide product registrations. You will also ensure ongoing compliance with regulatory agency 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: At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our 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 will include:
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.
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.
Requisition ID: 615058
Minimum Salary: $76000
Maximum Salary: $144400
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.
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.
Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
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.
Nearest Major Market:
Minneapolis Job Segment:
Regulatory Affairs, Medical Device, Compliance, Technical Writer, Law, Legal, Healthcare, Technology
#J-18808-Ljbffr