We anticipate the application window for this opening will close on - 30 May 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 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.

         

         

 

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.

Check us out on LinkedIn: Medtronic Pelvic Health

 

Onsite

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. 

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.   

 

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, 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. 

 

Key responsibilities: 

 

• 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.)