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Sr. Regulatory Specialist

2 months ago

St Paul, United States Boston Scientific Full time
Recruiter: 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.

About this role:

This role will be responsible for working on Boston Scientific's innovative Atrial Fibrillation technology, the FARAPULSE Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System was the first PFA technology that received a CE Mark in Europe and gained PMA approval in the US earlier this year. PFA technology is transforming ablation therapy on a global scale, and Boston Scientific is investing in portfolio development, robust clinical evidence, and global execution as we expand the capabilities and reach of this product with different indications.

The Sr Regulatory Affairs Specialist is responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals including change impact reviews.

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


Requisition ID: 588900