Sr Regulatory Affairs Specialist - Global Markets

Medtronic • Minneapolis, MN

1d • $92,000 - $138,000 • Onsite

About The Position

We anticipate the application window for this opening will close on - 3 Jul 2026. 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 Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey. SENIOR REGULATORY AFFAIRS SPECIALIST - Global Markets (High-Risk Devices) Neuromodulation Our Neuromodulation operating unit delivers advanced therapies for chronic pain, movement disorders, and nervous system conditions, offering SCS, DBS, and targeted drug delivery. Through proven technology, clinical evidence, and innovation, we provide personalized solutions that restore function and enhance quality of life. Check us out on LinkedIn: Medtronic Brain Modulation and Pain Interventions 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

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.
• 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.
• The employee is regularly required to be independently mobile.
• The employee is also required to interact with a computer, and communicate with peers and co-workers.
• Candidates must possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

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)

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)

What This Job Offers

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