Boston Scientific Regulatory Specialist - Electrophysiology Pulsed Field Ablation 

United States, Minnesota, Arden Hills 

360523108

Spencer Gregory Hale

Regulatory Specialist - Electrophysiology Pulsed Field Ablation, Regulatory Affairs

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:

• Supporting the development of domestic and international strategies for regulatory approval of Class I, II and III medical devices
• Coordinating, compiling, and submitting U.S. and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, IDEs, 510(k)s, PMA & IDE Annual Reports, and CE Mark submissions under MDR
• Supporting requests from BSC International Regulatory related to submissions, registrations, and change assessment
• Developing and maintaining positive relationships with regulatory body reviewers
• Technical and labeling reviews of supporting documents for inclusion in regulatory filings
• Reviewing of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
• Representing RA on cross functional projects which may include product development, manufacturing process changes, and continuous improvement efforts
• Supporting regulatory audits, as required

What we’re looking for in you:

Required Qualifications

• A minimum of a Bachelor's Degree
• A minimum of 2 years work experience in regulatory affairs or a combination of 3 years experience from a related field (R&D, Quality, Clinical, Medical Affairs, Biocompatibility) in the medical device industry
• Working knowledge of relevant US, EU, and/or international regulatory requirements for medical devices, including Quality Systems standards
• Effective written and oral communication, technical writing and editing skills
• Works well in fast-paced cross-functional team environments
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

Preferred Qualifications

• Bachelor's Degree in life sciences, engineering, or related field
• Previous experience with Class II or III medical devices submissions
• Experience working directly with FDA, notified bodies and/or international health authorities