Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Work mode : Hybrid

Onsite Location(s) : Arden Hills, MN, US, 55112

Additional Location(s) : N / A

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.

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 :

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

This role follows a hybrid work model, requiring employees to be in our local office in Arden Hills, MN 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 :

• Develop global strategies for regulatory approval of all medical device classifications
• Coordinate, author, compile, and submit U.S. and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, 510(k)s, Annual Reports, CE Mark submissions under MDR and US clinical investigation submissions
• Support requests from BSC International Regulatory personnel related to submissions, registrations, and change assessments and from clinical personnel related to international clinical investigation submissions
• Develop and maintain positive relationships with regulatory body reviewers
• Review Technical and Labeling documentation for inclusion in regulatory filings or as part of design changes
• Review product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
• Represent RA on cross functional projects which may include product development, sustaining changes, and continuous improvement efforts
• Support regulatory audits, as required
• In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures

Required Qualifications :

Preferred Qualifications :