Senior Regulatory Affairs Specialist - Global Markets - Onsite

Overview

Senior Regulatory Affairs Specialist with global responsibilities for strategy and submission management of high‑risk medical devices within Medtronic’s Neuroscience/Neuromodulation portfolio. This role partners with business units, geography regulatory teams, R&D, engineering, and manufacturing to develop regulatory strategies, lead worldwide submissions, respond to deficiencies, and ensure ongoing global compliance across markets.

• Develop and execute global regulatory submission strategies for new and modified medical devices; manage deficiency responses and product registrations across multiple markets.
• Assess and approve engineering changes, labeling updates, and product releases to maintain continuous regulatory compliance.
• Act as a liaison with international regulatory agencies at the reviewer level; support site registrations, audits, post‑market activities, and recalls as needed.
• Collaborate with R&D, engineering, and supply chain to identify regulatory obstacles and drive solutions throughout the product lifecycle.
• Maintain up‑to‑date knowledge of global regulations and standards; provide mentorship and training to junior team members.
• Lead strategic direction and planning for global regulatory projects to ensure timely market approvals and ongoing compliance.

• Must Have: Bachelor’s degree in a scientific discipline or equivalent; minimum 4 years of regulatory affairs experience in the medical device industry (advanced degree with 2+ years acceptable).
• Nice to Have: 5–8 years of regulatory affairs experience; advanced degree; experience with MDR, ISO 14971, ISO 13485, MDSAP; track record of international device submissions (LATAM, APAC, CEEMEA); experience with Class III devices (PMA); understanding of U.S./global regulatory requirements and quality systems.

The role requires regular office work; reasonable accommodations are available. U.S. work authorization sponsorship is offered at Principal level and above; roles below Principal require unrestricted U.S. work authorization.

Medtronic is an equal employment opportunity employer. We provide reasonable accommodations for qualified individuals with disabilities. The company offers a broad benefits package including health/dental/vision coverage, retirement plans, paid time off, and other compensation programs. Salary ranges and benefits specifics vary by location and are disclosed to candidates hired within the United States; local market compensation applies for other regions.