Principal Regulatory Affairs Specialist: Pelvic Health
About The Position
This is an add position with a special focus on developing clinical strategies and clinical study support worldwide. This individual will also perform other regulatory duties. As one of three comprehensive portfolios at Medtronic, Neuroscience is dedicated to improving the lives of people living with neurological disorders, spine conditions, and chronic pain. Guided by our Mission—to alleviate pain, restore health, and extend life—we develop technologies and therapies that help people regain function, reduce pain, and return to the activities that matter most. Our Pelvic Health Operating Unit advances care for patients living with bladder and bowel control conditions through targeted, minimally invasive neuromodulation therapies, including sacral and tibial solutions. Designed to modulate nerve pathways and restore communication between the brain and pelvic floor, these programmable therapies deliver personalized treatment supported by strong clinical evidence and long-term outcomes—helping improve confidence, independence, and quality of life. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week at our Minnesota Rice Creek East facility to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. Prefer a candidate located in the Minneapolis area or who can relocate there. We are looking for a passionate Principal Regulatory Affairs Specialist with experience developing global regulatory strategies and leading worldwide Clinical Trial Applications (CTAs) for our innovative, high-risk medical device portfolio.
Requirements
- Bachelor’s degree in life science, engineering, or a related field
- Minimum 7 years of relevant experience, or an advanced degree with 5+ years of experience.
Nice To Haves
- 7-10 years of industry experience, with at least 4-5+ years in regulatory, clinical, or quality roles.
- Proven track record of successful high-risk medical device clinical trial applications (e.g., IDE, ITA, CTA) worldwide.
- Advanced degree in a scientific, health, or engineering discipline.
- Expert knowledge of global clinical trial authorization regulations, regional risk classifications, and ISO 14155 (GCP) standards.
- Experience with real-world evidence (RWE), AI/ML applications, or digital health technologies.
- Experience in claim development and/or performing advertising and promotion reviews for class III /PMA medical devices.
- Exposure to reimbursement/market access strategies.
- History of successful device submissions in a US Class III PMA environment.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Responsibilities
- Develop, prepare, and manage high-quality clinical trial regulatory dossiers (e.g., IDEs in the US, CTAs in Europe/MDR, ITA in Canada) to obtain approval for initiating clinical studies worldwide.
- Define and execute global regulatory strategies for high-risk (Class III) devices, providing guidance on pre-clinical and clinical data requirements.
- Act as the direct liaison between the company and Regulatory Authorities (FDA, Notified Bodies) or with in-country regulatory partners (Competent Authorities, Health Canada, TGA, etc.) regarding trial applications, amendments, and annual reports.
- Monitor, analyze, and communicate changes in global regulations (e.g., EU MDR, FDA, Health Canada, TGA, etc.) affecting clinical research and device development.
- Partner with Clinical Affairs, R&D, Quality, and Marketing to review clinical protocols, informed consent forms, and investigator brochures for compliance with GCP and local requirements.
- Author and review regulatory submission technical dossiers, design history files, and clinical evaluation reports (CERs).
- Support pre- and post- market regulatory activities for high-risk medical devices, including: Ensuring regulatory compliance (e.g., clinical trial audits, site registrations, device approvals, vigilance reporting, and recalls). Supporting the development and review of marketing, advertising, and promotional materials. Providing feedback and regulatory guidance to product development teams. Managing regulatory support for marketed products, including labeling reviews and change control documentation.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Principal
