Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist – Medtronic Location: Mounds View, MN or Danvers, MA. Open application window until August10,2026. Role Summary The Senior Regulatory Affairs Specialist will provide strategic leadership for regulatory affairs in support of new product development and introduction within Medtronic’s Interventional Cardiology Therapies (ICT) operating unit. The role focuses on shaping and executing global regulatory strategies across multiple regions, overseeing pre‑market submissions, and mentoring junior team members. Responsibilities Develop and execute global regulatory strategies for new product development and introduction, including software‑based solutions and hardware. Advise cross‑functional teams on regional regulatory requirements (FDA, EU MDR, NMPA, PMDA, TGA). Identify and recommend optimal regulatory pathways (e.g., 510(k), PMA, IDE, CE Mark, EU Technical Files, China NMPA registration, Japan PMDA Shonin, Australia TGA conformity assessments). Lead regulatory risk assessments during product design and development, providing solutions to minimize approval delays. Author, review, and lead global pre‑market regulatory submissions. Drive regulatory agency interactions, including FDA Pre‑Sub meetings, Notified Body consultations, PMDA pre‑consultations, and Scientific Advice processes. Represent the company during negotiations and reviews with FDA, Notified Bodies, NMPA, PMDA, and TGA. Represent the Regulatory Affairs function on product development teams to support compliant regulatory strategies. Partner with cross‑functional team members to lead engagements with regulatory agencies for new and existing devices. Lead and influence the preparation of documentation to support innovative and high‑quality regulatory submissions from early‑phase strategies, marketing applications, and change management implementation. Engage and actively participate in compliance activities, identifying opportunities for improved efficiencies. Act as a mentor to colleagues and manage an extended team. Stay current on regulation and guidance changes, supporting advocacy work as needed. Work with functional team members to ensure clear communication of project objectives, deliverables, and key milestones. Partner in problem resolution to mitigate challenges and keep objectives aligned with program estimates. Work within a matrixed, collaborative team environment focused on meeting business objectives. Minimum Requirements Bachelor’s degree in a technical discipline. Minimum of 4years of direct Regulatory Affairs experience within the medical device industry, or an advanced degree with a minimum of 2years of experience. Medical device industry experience with Class I/II/III/IV software products. Position is not eligible for immigration sponsorship; applicants must be authorized to work without sponsorship. Nice to Have Direct Regulatory Affairs experience supporting programs throughout the software development life cycle. Experience performing advertising and promotion reviews/approvals for medical devices. Experience leading early interactions with regulatory authorities. Advanced degree in a scientific discipline (engineering, physical/biological or health sciences). Working knowledge of Project Management methodologies and tools; PMP certification is an asset. Strong business acumen, planning, interpersonal, quantitative analysis, and problem‑solving skills. High degree of initiative and influence management skills; results oriented and able to drive completion on aggressive schedules. Ability to manage multiple projects and proficiency with Microsoft Office and software tools. For Baccalaureate degrees earned outside the United States, a degree that satisfies the requirements of 8C.F.R. §214.2(h)(4)(iii)(A) is required. Disclaimer Medtronic is an equal‑employment‑opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, disability, or any other protected characteristic. Medtronic will provide reasonable accommodations to qualified individuals with disabilities. #J-18808-Ljbffr MCV Medtronic CoreValve LLC