Senior Regulatory Affairs Lead – Medical Devices

Boston Scientific; Maple Grove (MN); Hybrid; USD 107.000 - 203.000; Vollzeit

Zusammenfassung

Boston Scientific in the United States is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategies for innovative medical devices. You will plan and manage submissions to the FDA, EU notified bodies and other international authorities, and collaborate with cross-functional teams.

The role requires 5+ years in regulatory affairs, strong writing and editing skills, and experience with PMAs, 510(k)s, and MDR technical documentation.

Qualifikationen

• Bachelor's degree.
• Minimum of 5 years' experience in regulatory affairs or related medical device discipline.
• Demonstrated experience authoring or supporting U.S. and EU regulatory submissions, including PMA supplements, 510(k) submissions and EU MDR technical documentation.
• Proficiency in Microsoft Word, Excel, PowerPoint and Adobe Acrobat, including preparation of regulatory submissions and presentations.

Aufgaben

• Serve as a company representative, developing and maintaining positive relationships with regulatory agency reviewers through written and verbal communications regarding regulatory strategies, submission pathways, testing requirements and submissions under review.
• Coordinate, compile and submit U.S. and EU regulatory filings for new and modified medical devices, including premarket approval applications (PMAs), PMA supplements, pre-submissions, 510(k) submissions, annual reports and CE marking submissions under the EU Medical Device Regulation (MDR).
• Develop and implement domestic and international regulatory strategies for new and modified Class II and Class III medical devices.
• Support the implementation and continuous improvement of departmental policies and procedures.
• Provide regulatory affairs training and guidance to cross-functional teams.

Kenntnisse

Regulatory affairs

PMA & 510(k) submissions

Cross-functional collaboration

Project management

Excellent written & verbal comms

Ausbildung

Bachelor's degree

Tools

Microsoft Word

Excel

PowerPoint

Adobe Acrobat

Jobbeschreibung

Boston Scientific in the United States is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategies for innovative medical devices. You will plan and manage submissions to the FDA, EU notified bodies and other international authorities, and collaborate with cross-functional teams.

The role requires 5+ years in regulatory affairs, strong writing and editing skills, and experience with PMAs, 510(k)s, and MDR technical documentation.