Senior Regulatory Affairs Specialist - Global Markets - Onsite
About The Position
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. The Pelvic Health Operating Unit advances care for patients living with bladder and bowel control conditions through targeted, minimally invasive neuromodulation therapies. 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.
Requirements
- Bachelor’s degree in a scientific discipline or equivalent
- Minimum 4 years of regulatory affairs experience in the medical device industry, or an advanced degree with 2 years of experience.
- 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.
- Possess unrestricted U.S. work authorization at the time of hire and for the duration of employment (for roles below Principal level).
Nice To Haves
- 5-8 years of medical device industry experience in regulatory affairs.
- Advanced degree in a scientific, engineering, or health discipline.
- In-depth experience with global regulatory requirements, including MDR, ISO 14971, ISO 13485, MDSAP, and quality standards
- History of successful international device submissions, including LATAM, APAC, and CEEMEA regions
- Experience with Class III medical devices (PMA)
Responsibilities
- Develops global regulatory strategies and leads worldwide submissions for high-risk medical devices.
- Manages strategy meetings, submissions, and deficiency responses to ensure approval for new product entry and device changes.
- Ensures global compliance, participates in audits, and provides support to project teams.
- 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.
- Provide regulatory assessments and approvals for engineering change orders, labeling changes, and product releases to ensure continuous compliance across global markets.
- Act as a key liaison to international regulatory agencies at the reviewer level; support manufacturing site registrations, audits, post-market vigilance, and product recalls.
- Collaborate with R&D, engineering, and supply chain teams to identify, address, and resolve potential regulatory obstacles and compliance blocks throughout the product lifecycle.
- Maintain up-to-date knowledge of global regulations and industry standards to inform company strategy; provide guidance and training to junior team members.
- Lead the strategic direction and planning for global regulatory projects, ensuring timely market approvals and compliance with applicable regulations.
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)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
