Principal Regulatory Affairs Specialist: Pelvic Health

Job description

We anticipate the application window for this opening will close on - 13 Jun 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the LifeThis 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. Pelvic Health 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. Check us out on LinkedIn: Medtronic Pelvic Health 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. Role Overview The Principal Regulatory Affairs Specialist develops global regulatory strategies and leads worldwide clinical trial applications for high-risk medical devices. They will manage strategy meetings and submissions to the FDA and EMA (under the EU MDR), discuss with the Notified Body, and coordinate with international regulatory partners for global approvals. Additionally, the specialist develops and executes strategies for new product introductions and lifecycle changes. Responsibilities may include the following and other duties may be assigned. Global Clinical Trial Submissions: 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. Regulatory Strategy: Define and execute global regulatory strategies for high-risk (Class III) devices, providing guidance on pre-clinical and clinical data requirements. Agency Interaction: 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. Regulatory Intelligence: Monitor, analyze, and communicate changes in global regulations (e.g., EU MDR, FDA, Health Canada, TGA, etc.) affecting clinical research and device development. Cross-Functional Collaboration: 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. Technical Documentation: Author and review regulatory submission technical dossiers, design history files, and clinical evaluation reports (CERs). Product support and maintenance: 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. Must Have: Minimum 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 Have 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. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$120,000.00 - $180,000.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal