Prin Regulatory Affairs Spec

A Day in the Life The Principal Regulatory Affairs Specialist will play a key role in launching new products and sustaining the Wound Management product portfolio. As a core member of the new product development (NPD) team, the specialist will work directly with the NPD team from the opportunity phase through commercialization, ensuring compliance with US and EU regulatory requirements and supporting regulatory submissions worldwide for Wound Management devices. Responsibilities Provide regulatory affairs domain expertise and influence at all levels in support of the Wound Management device portfolio Offer strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering both domestic and international regulations Prepare Pre‑Sub, 510(k) and other technical documents to support CE mark and other international submissions Participate in negotiations and interactions with regulatory authorities during the development and review process Provide business and product information to the international regulatory affairs team to enable development and strategy and communicate findings to the business team Support international product registrations as needed Manage multiple projects and prioritize tasks daily to meet project schedules Collaborate with engineering, quality, clinical, marketing, and other functions to fulfill responsibilities Review promotional and advertising material for regulatory compliance Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards Create or revise departmental procedures to improve operations or reflect changing regulatory requirements Participate in internal and external audits Maintain regulatory affairs documentation to support compliance with applicable regulatory requirements Perform other duties as assigned or required Minimum Requirements Bachelor’s degree required Minimum of 7 years of relevant experience, or an advanced degree with a minimum of 5 years of relevant experience Nice to Have Experience successfully achieving FDA clearance through a 510(k) submission Experience interacting directly with the FDA Experience managing or contributing to multiple regulatory submissions Familiarity with medical device regulatory lifecycle management Physical Job Requirements Regular independent mobility, interaction with a computer, and communication with peers and co‑workers are required. Reasonable accommodations may be made for individuals with 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 candidates to possess unrestricted U.S. work authorization at the time of hire. Benefits & Compensation Medtronic offers a competitive salary and flexible benefits package. Salary ranges for U.S. (excl. PR) locations (USD) range from $120,000.00 to $180,000.00. The position is eligible for the Medtronic Incentive Plan and other short‑term incentives. Benefits for full‑time employees include health, dental, vision, Health Savings Account, Healthcare Flexible Spending Account, life insurance, long‑term disability leave, dependent daycare account, tuition assistance, 401(k) with employer match, short‑term disability, paid time off, paid holidays, stock purchase plan, and Employee Assistance Program. Equal Employment Opportunity (EEO) Statement 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 and/or expression, genetic information, marital status, or any other characteristic protected by federal, state, or local law. Medtronic will provide reasonable accommodations for qualified individuals with disabilities. #J-18808-Ljbffr Medtronic