Senior Regulatory Affairs Specialist
3 weeks ago
Senior Regulatory Affairs SpecialistJoin our Peripheral Interventions Team, where we create the next generation of cryoablation systems designed to treat abnormal tissue. Our products 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, EU notified bodies, as well as supporting world-wide product registrations. This role will contribute to new product development efforts, including the next generation of cryoablation systems, while also ensuring ongoing compliance with regulatory agency requirements, such as conducting change impact assessments.At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model, requiring employees to be in our local office in Maple Grove, 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:Support the development of domestic and international strategies for Class II medical devicesRepresent RA on cross functional projects which may include product development, manufacturing process changes, and continuous improvement effortsReview and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulationsCoordinate, compile, and submit US and EU regulatory filings for new and modified products, including pre-submissions, 510(k)s, and CE Mark submissions under MDRSupport international geographies to gain and maintain product approvalsSupport efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharingSupporting regulatory audits, as requiredRequired Qualifications:Bachelor's degree, minimum4+ years of experience in Regulatory Affairs or a related discipline in the medical device industry (such as R&D, Quality, Clinical, Biocompatibility, or Labeling), with at least 2 of those years specifically in Regulatory AffairsDemonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as US 510(k)s and EU MDR technical documentationBasic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe AcrobatPreferred Qualifications:Previous experience supporting medical electrical equipmentGeneral understanding of product development process and design controlsWorking knowledge of US FDA, EU, and international regulationsAbility to manage several projectsEffective research and analytical skillsEffective written and oral communication, technical writing and editing skillsWorks well in fast-paced cross-functional team environmentsTeam player with excellent interpersonal skills
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Regulatory Affairs Specialist II
3 weeks ago
Maple Grove, United States Boston Scientific Full timeRegulatory Affairs Specialist IIThis Regulatory Affairs Specialist II role will provide regulatory support across a broad portfolio of Interventional Cardiology devices, with a primary focus on U.S. and EU compliance activities. Responsibilities include support for U.S. Annual Reports, EU MDR PSUR and SSCP annual reviews, EU MDR recertification activities,...
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Principal Regulatory Affairs Specialist
4 days ago
Maple Grove, United States Minnesota Staffing Full timePrincipal Regulatory Affairs SpecialistDiversity - 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...
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Regulatory Affairs Specialist II
3 weeks ago
Maple Grove, United States Minnesota Jobs Full timeRegulatory Affairs Specialist IIAt 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,...
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Regulatory Affairs Specialist
3 weeks ago
Maple Grove, United States Actalent Full timeRegulatory Affairs SpecialistWe are seeking a dedicated Regulatory Affairs Specialist to join our team. This role involves reviewing, editing, and finalizing engineering test reports and other technical deliverables to support regulatory submissions under FDA, EU MDR, and other global frameworks. You will prepare and support U.S. and international regulatory...
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Senior Regulatory Affairs Specialist
2 weeks ago
Maple Grove, MN, United States Boston Scientific Full timeAdditional Location(s): N/A 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...
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Senior Regulatory Affairs Specialist
7 days ago
Maple Grove, MN, United States Boston Scientific Full timeAdditional Location(s): N/A 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...
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Regulatory Affairs Specialist
4 weeks ago
Maple Grove, United States Anteris Tech Full timeRegulatory Affairs SpecialistAnteris is a science-driven structural heart company that is redefining expectations and advancing the field through cutting-edge solutions focused on restoring native-like physiology versus treating symptoms of structural heart disease. We are currently developing a new class of TAVR designed to mimic the performance of a...
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Regulatory Affairs Specialist II
3 weeks ago
Maple Grove, United States Minnesota Staffing Full timeInterventional Cardiology Regulatory Affairs Specialist IIDiversity - 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....
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Principal Regulatory Affairs Specialist
4 weeks ago
Maple Grove, United States Boston Scientific Full timePrincipal Regulatory Affairs SpecialistThe Principal Regulatory Affairs Specialist will lead the development and execution of U.S. and EU regulatory strategies to bring innovative Peripheral Vascular productsparticularly drug-eluting devicesto market. This role supports both new product development and ongoing compliance for a broad vascular portfolio,...
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Principal Regulatory Affairs Specialist
2 weeks ago
Maple Grove, United States Boston Scientific Full timePrincipal Regulatory Affairs SpecialistAt 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...
