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Boston Scientific · 13 hours ago

Senior Regulatory Affairs Specialist - Vascular Therapies

Arbor Lakes, MN

Full-time

Hybrid

Mid, Senior Level

$85K/yr - $162K/yr

4+ years exp

Boston Scientific is a leader in medical science committed to solving important health industry challenges. The Senior Regulatory Affairs Specialist is responsible for planning, managing, and implementing regulatory submissions to the US FDA and EU notified bodies, ensuring compliance with regulatory agency approvals.

Health CareMedicalMedical Device

No H1B

Responsibilities

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

Qualification

Regulatory AffairsMedical DevicesRegulatory SubmissionsU.S. FDA RegulationsEU RegulationsTechnical WritingProject ManagementMicrosoft OfficeAnalytical SkillsInterpersonal SkillsProblem-Solving SkillsTeam Player

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