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Boston Scientific · 17 hours ago

Regulatory Affairs Specialist III

US-MN-Arden Hills

Full-time

Hybrid

Mid Level

$76K/yr - $144K/yr

3+ years exp

Boston Scientific is a leader in medical science dedicated to solving significant health industry challenges. The Regulatory Affairs Specialist III will play a critical role in advancing innovative Atrial Fibrillation technology by managing regulatory submissions and ensuring compliance with agency approvals.

Health CareMedicalMedical Device

No H1B

Responsibilities

Support the development of domestic and international strategies for regulatory approval of Class I, II, and III medical devices

Represent Regulatory Affairs on cross-functional projects, including 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 regions to gain and maintain product approvals

Contribute to continuous improvement of departmental and divisional quality through collaboration, best practices, and knowledge sharing

Support regulatory audits, as required

Qualification

Regulatory AffairsMedical DevicesRegulatory SubmissionsFDA RegulationsEU RegulationsProject ManagementAnalytical SkillsMicrosoft OfficeTechnical WritingCommunication SkillsTeam Collaboration

Required

Bachelor's degree

Minimum of 3 years' experience in Regulatory Affairs or a related discipline within medical devices (R&D, Quality, Clinical, Biocompatibility, Labeling)

Demonstrated experience authoring and 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

Proficiency with submission and presentation-related computer skills, including Microsoft Word, Excel, PowerPoint, and Adobe Acrobat