Senior Regulatory Affairs Specialist - Global Markets - Onsite

Medtronic • Minneapolis, MN

4d • Onsite

About The Position

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. 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.

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.
• Possess unrestricted U.S. work authorization at the time of hire and for the duration of employment (for non-Principal level roles).

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)
• 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.

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
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
• Paid sick time (for temporary employees, as required under applicable state law)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior