Senior Regulatory Affairs Specialist

Senior Regulatory Affairs SpecialistWork mode: HybridOnsite Location(s): Arden Hills, MN, US, 55112Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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 classificationsCoordinate, 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 submissionsSupport requests from BSC International Regulatory personnel related to submissions, registrations, and change assessments and from clinical personnel related to international clinical investigation submissionsDevelop and maintain positive relationships with regulatory body reviewersReview Technical and Labeling documentation for inclusion in regulatory filings or as part of design changesReview product and manufacturing changes for compliance with applicable regulations and impact to regulatory filingsRepresent RA on cross functional projects which may include product development, sustaining changes, and continuous improvement effortsSupport regulatory audits, as requiredIn 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 proceduresRequired Qualifications:A minimum of a Bachelor's DegreeA minimum of 4 years of regulatory affairs or related experienceDemonstrated experience authoring a variety of regulatory submissions for US and EUComputer skills, including experience with Microsoft Word, Excel, PowerPoint and Adobe AcrobatPreferred Qualifications:Previous experience in the medical device industry with Class II or III device submissionsExperience working directly with FDA, notified bodies and/or international health authoritiesStrong technical, research and problem-solving skillsAbility to articulate complex ideas clearly both verbally and in writingTeam player with excellent interpersonal and communication skillsDemonstrated ability to effectively manage multiple projects and prioritiesWorks well in fast-paced cross-functional team environment