Regulatory Affairs Specialist II
3 weeks ago
Regulatory 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, audit support, and general compliance initiatives. The role may also include support for new product introductions, evaluation of post-market design changes, and process optimization effortsaligned with global medical device regulations and broader business objectives.This is a hybrid position based in Maple Grove, MN (in office at least three days per week).Your responsibilities will include:Represent Regulatory Affairs on core teams, providing regulatory feedback and guidance throughout the project or product development cycleAct as a company representative, developing and maintaining positive relationships with regulators through oral and written communications regarding pre-submission strategies, regulatory pathway development, and full submission review processesPrepare and submit regulatory documentation and applications focused on compliance requirementsReview and approve product and manufacturing changes, device labeling, and advertising materials for regulatory complianceSupport and maintain quality initiatives in accordance with Boston Scientific's Quality PolicyParticipate in the development and implementation of departmental policies and proceduresContinuously assess ways to improve quality and compliance practicesProvide internal and external audit preparation and supportSupport innovation within Regulatory Affairs by proposing process optimization and efficiency strategiesQualifications:Required qualifications:Minimum of a bachelor's degree in a scientific, technical, or related disciplineMinimum of 2 years' experience in Regulatory Affairs or related fields (e.g., Quality, Clinical, R&D) within the medical device industry, including at least 1 year in a Regulatory Affairs roleIntroductory knowledge of FDA and EU regulations for medical devicesBasic computer skills, including proficiency in Microsoft Word, Excel, Teams, PowerPoint, and Adobe AcrobatPreferred qualifications:Working knowledge of FDA, EU, and international regulations for medical devicesAbility to manage multiple projects of moderate scope and complexity simultaneously while meeting deadlinesEffective research, analytical, and problem-solving skillsExcellent written and oral communication, technical writing, and editing skills; ability to translate technical information into clearly written regulatory messagingAdvanced computer skills to support submission preparation and internal/external communication (e.g., MS Word linkages, section formatting, table of contents creation)Self-motivated, quick learner who can work independently with minimal supervisionComfortable working in fast-paced, cross-functional team environmentsCompensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
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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 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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Regulatory Affairs Specialist II
1 week ago
Maple Grove, 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...
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Principal Regulatory Affairs Specialist
3 weeks 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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Senior Regulatory Affairs Specialist
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Maple Grove, United States Boston Scientific Full timeSenior 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...
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Regulatory Affairs Specialist II
1 week ago
Maple Grove, Minnesota, United States Boston Scientific Full time $90,000 - $120,000 per yearYour responsibilities will include: Supporting Regulatory Affairs activities related to Renal Denervation devices within the Interventional Cardiology portfolio Supporting department and divisional process improvements through collaboration, best practice sharing, and cross-functional engagement A minimum of a Level 8 HETAC qualification in Science,...
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Principal Regulatory Affairs Specialist
3 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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Principal Regulatory Affairs Specialist
2 weeks ago
Maple Grove, United States Boston Scientific Gruppe Full timeOverview 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 tools, information, and training, we’ll help you in advancing your skills and career. Here, you’ll be...
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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...
