Senior Regulatory Affairs Specialist

3 weeks ago

Maple Grove, United States Boston Scientific Full time

Senior Regulatory Affairs Specialist - Vascular TherapiesJoin our Interventional Cardiology and Vascular Therapies team, where we create innovative technologies to diagnose and treat peripheral vascular disease. Our productsincluding medical electrical equipment such as consoles, catheters, and other associated devicesimprove 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.Work model, sponsorship, relocation: 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.Your responsibilities will include: 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 requiredRequired qualifications: 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 AcrobatPreferred qualifications: 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

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