Sr. Regulatory Affairs Specialist - Global Markets

Medtronic • Minneapolis, MN

4d • Onsite

About The Position

At Medtronic, 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. 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.

Requirements

• Minimum Requirements Bachelor’s degree in a scientific discipline or equivalent with 4 years of relevant experience, or an advanced degree with 2 years of experience.

Nice To Haves

• A minimum of 2 years of experience in medical device regulatory affairs.
• Knowledge in global regulations, including ISO 13485, MDSAP, and MDR
• 5-8 years of industry experience, with at least 2-3 years in regulatory, engineering, clinical, or quality roles.
• 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

• 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 up-to-date knowledge of global regulations and industry standards to inform company strategy; provide guidance and training to junior team members.
• Strategic Focus: 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)

What This Job Offers

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