Principal Regulatory Affairs Specialist: Pelvic Health
MedtronicAbout the role
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
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.
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 requireme
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