MED Medtronic Inc · Minneapolis, MN

Principal Regulatory Affairs Specialist: Pelvic Health at MED Medtronic Inc — Minneapolis, MN

Full-timeMinneapolis, MNPosted 2026-07-15Apply on Workday
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Full job description

A Day in the Life

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.

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.

  • 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.

Physical Job Requirements

U.S. Work Authorization & Sponsorship

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Benefits & Compensation

Salary ranges for U.S (excl. PR) locations (USD):$120,000.00 - $180,000.00