Regulatory Specialist III - Electrophysiology Pulsed Field Ablation

Additional Location(s): US-MN-Arden Hills

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

 

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.       

 

About the role:

This role will be responsible for working on Boston Scientific’s most recently acquired novel 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. PFA technology has the potential to alter the future of ablation therapy on a global scale as we expand the reach of this product into other geographies and with different indications. 

 

The Regulatory Affairs Specialist III 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. 

 

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 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 

 

Required qualifications:  

• Bachelor’s degree 
• 3+ years Regulatory Affairs or related discipline in medical devices (R&D, Quality, Clinical, Biocompatibility)
• Demonstrated experience authoring/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
• Basic submission and presentation related computer skills, including experience with the software applications 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 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 
• Proven ability to influence without authority
• Works well in fast-paced cross-functional team environments
• Boston Scientific experience, capital equipment and/or single use sterilized devices 

 

#LI-Hybrid

 

 

 

Requisition ID: 603139

Minimum Salary: $76000 

Maximum Salary: $144400 

 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

 

Compensa