Regulatory Affairs Specialist

Job Overview Regulatory Affairs Specialist – Onsite (4 days per week). Application window closes 30 Mar 2026. Role Overview The Regulatory Affairs Specialist develops strategies for worldwide product registration with Medtronic’s regulatory partners and global agencies, assisting product development and change management. Key Responsibilities Provide advice on regulatory requirements. Prepare and assist with regulatory submissions to the FDA, EU MDR, and other agencies. Negotiate approval and manage license maintenance, including annual reports, renewals, design/manufacturing change notifications, QMS audits, and manufacturing site registrations. Collaborate with engineers, technical experts, and international regulatory staff to resolve potential issues. Prepare FDA, European, and Canadian submissions for product changes. Review regulatory issues with the manager and resolve submission issues. Support compliance activities: manufacturing site registration, audits, post‑market vigilance reporting, product recalls. Provide regulatory support for marketed products, review labeling and changes. Provide feedback and ongoing support to product development teams. Interact directly with FDA and international agencies at reviewer level. Qualifications Medical device experience, particularly with Class III medical devices (PMA). Proven experience preparing and submitting regulatory filings to the FDA, EU MDR, and other global agencies. In‑depth understanding of FDA requirements, guidance documents, EU MDR, ISO 14971, ISO 13485, and other quality standards. Strong communication, negotiation, written and oral skills. Organizational skills: multitasking, prioritizing, meeting deadlines. Ability to work independently under general direction. Proficiency in MS Office, MS Project, Adobe Acrobat, and Agile. Minimum Requirements Bachelor’s degree in a scientific discipline or equivalent with 2 years of relevant experience, or an advanced degree with 0 years of experience. Nice to Have 1‑2 years of industry experience, at least 1‑2 years in regulatory, clinical, or quality roles. Advanced degree in a scientific discipline (engineering, physical/biological, or health sciences). Experience working in a regulated biotechnology environment and extensive involvement in regulatory submissions. History of successful device submissions. Cybersecurity/software experience (strong plus). For Baccalaureate degrees earned outside of the United States, certification meeting 8C.F.R. §214.2(h)(4)(iii)(A). Physical Job Requirements The role requires independent mobility, computer interaction, and communication with peers. Reasonable accommodations may be made for disabilities. U.S. Work Authorization & Sponsorship U.S. work authorization sponsorship is offered exclusively for Principal‑level roles and above. Roles below the Principal level require unrestricted U.S. work authorization at the time of hire. Benefits & Compensation Competitive salary range for U.S. locations (excluding Puerto Rico): $73,600–$110,400 (USD). Eligible for the Medtronic Incentive Plan (MIP) short‑term incentive. Additional benefits include health, dental, vision insurance; Health Savings Account; flexible spending account; life insurance; long‑term disability; childcare; tuition assistance; 401(k) with match; paid time off; employee stock purchase plan; employee assistance program; and more. Benefit details apply to regular employees; temporary employees may receive partial benefits. Equal Employment Opportunity It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, disability, race, religion, creed, gender, sex, sexual orientation, gender identity, or other protected characteristics. Medtronic will provide reasonable accommodations for qualified individuals with disabilities. #J-18808-Ljbffr