Principal Regulatory Affairs Spec ; Pelvic Health

Medtronic•Minneapolis, MN

1d•Onsite

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. PRINCIPAL REGULATORY AFFAIRS SPECIALIST – Global Clinical Trials (High-Risk Devices) 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. We are looking for a passionate Principal Regulatory Affairs Specialist who has experience developing global regulatory strategies and leading worldwide Clinical Trial Applications (CTA) for our innovative high-risk medical device portfolio. 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, EMA (under EU MDR), discussions with the Notified Body, and coordinates with international regulatory partners for global approvals. Additionally, the specialist develops and executes strategies for new product introductions and lifecycle changes.

Requirements

Bachelor’s degree in life science, engineering, or related field with 7 years of relevant experience, or an advanced degree with 5+ years of experience.
Proven track record of successful high-risk medical device clinical trial applications (e.g., IDE, ITA, CTA) worldwide.

Nice To Haves

7-10 years of industry experience, with at least 4-5+ years in regulatory, clinical, or quality roles.
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)