Senior Regulatory Affairs Specialist - Global Markets - Onsite
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
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.
We are looking for a passionate Senior Regulatory Affairs Specialist who has experience developing global regulatory strategies in partnership with our business unit project teams and geography regulatory partners for our innovative high-risk medical device portfolio.
Role Overview
The Sr. Regulatory Affairs Specialist develops global regulatory strategies and leads worldwide submissions for high-risk medical devices. They will manage strategy meetings, submissions, and deficiency responses to ensure approval for new product entry and device changes. They will also ensure global compliance, participate in audits, and provide support to project teams.
Key Responsibilities
Global Regulatory Strategy & Submissions: Partner with business unit and geography regulatory teams to develop and execute global submission strategies, deficiency responses, and product registration plans for new and modified products.
Product Lifecycle Management: Provide regulatory assessments and approvals for engineering change orders, labeling changes, and product releases to ensure continuous compliance across global markets.
Agency Interaction & Compliance: Act as a key liaison to international regulatory agencies at the reviewer level; support manufacturing site registrations, audits, post-market vigilance, and product recalls.
Cross-Functional Technical Support: Collaborate with R&D, engineering, and supply chain teams to identify, address, and resolve potential regulatory obstacles and compliance blocks throughout the product lifecycle.
Regulatory Intelligence & Mentorship: Maintain
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