Senior Regulatory Affairs Specialist - Vascular Therapies

Senior Regulatory Affairs Specialist - Vascular Therapies

Onsite Location(s): Maple Grove, MN, US, 55311

Additional Location(s): US-MN-Maple Grove

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.

Join our Interventional Cardiology and Vascular Therapies team, where we create innovative technologies to diagnose and treat peripheral vascular disease. Our products—including medical electrical equipment such as consoles, catheters, and other associated devices—improve patient outcomes and enhance lives by providing the most advanced and broadest set of therapy solutions.

The Senior Regulatory Affairs Specialist is responsible for planning, managing, and implementing regulatory submissions to the US FDA and EU notified bodies, as well as supporting world-wide product registrations. This role also ensures ongoing 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.

• Supporting the development of domestic and international strategies for Class II and III medical devices
• Representing Regulatory Affairs on cross-functional projects, including product development, manufacturing process changes, and continuous improvement efforts
• Reviewing and approving design and manufacturing changes for existing products to ensure compliance with applicable regulations
• Coordinating, compiling, and submitting U.S. 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
• Supporting international geographies to gain and maintain product approvals
• Driving continuous improvement in department and divisional quality practices, collaboration, and knowledge sharing
• Supporting regulatory audits, as required

• Bachelor’s degree in a relevant field
• Minimum of 4 years' experience in Regulatory Affairs or a related discipline in medical devices (e.g., R&D, Quality, Clinical, Biocompatibility, Labeling)
• Demonstrated experience authoring or supporting a variety of regulatory submissions for the U.S. and EU, including 510(k) s and MDR technical documentation
• Proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat

• Experience supporting medical electrical equipment, including consoles
• Experience with regulatory support for software and cybersecurity
• General understanding of the product development process and design controls
• Working knowledge of U.S. FDA, EU, and international medical device regulations
• Ability to manage multiple projects simultaneously
• Strong research, analytical, and problem-solving skills
• Excellent written and verbal communication, technical writing, and editing skills
• Ability to thrive in fast-paced, cross-functional team environments
• Team player with strong interpersonal skills

Requisition

Minimum Salary: $85000

Maximum Salary: $161500

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see — 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…