Regulatory Affairs Specialist III

Boston Scientific • Arden Hills, MN

4d • $76,000 - $144,400 • Hybrid

About The Position

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.

Requirements

• Bachelor’s degree.
• 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.

Nice To Haves

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees