Boston Scientific Sr Regulatory Specialist - Electrophysiology Pulsed Field Ablation 

United States, Minnesota, Arden Hills 

990782762

Spencer Gregory Hale

Sr. Regulatory Specialist - Electrophysiology Pulsed Field Ablation

At Boston Scientific, you’ll discover a place where you can have meaningful purpose, improving lives through your life's work. In Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure and protecting against sudden cardiac arrest. We continue to innovate in key areas and extending our products into new geographies and high-growth adjacency markets.

Your responsibilities will include:

• Support the development of domestic and international strategies for regulatory approval of Class III electronic medical equipment devices.
• Represent RA on cross functional projects which may include 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 geographies to gain and maintain product approvals.
• Support efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing.
• Supporting regulatory audits, as required

What we’re looking for in you:

Minimum Qualifications

• Bachelor’s degree, minimum
• 5+ years Regulatory Affairs or related discipline in medical devices (R&D, Quality, Clinical, Biocompatibility, Labeling)
• Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as US 30 day notices and annual reports and EU MDR technical documentation.
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat
• Works well in fast-paced cross-functional team environments

Preferred Qualifications

• Previous experience in the medical device industry with Class II or III device submissions
• General understanding of product development process and design controls
• Working knowledge of FDA, EU and international regulations
• Ability to manage several projects
• Effective research and analytical skills
• Effective written and oral communication, technical writing and editing skills