Principal Regulatory Affairs

We anticipate the application window for this opening will close on - 23 Sep 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 The Principal Regulatory Affairs Specialist will play a key role in launching new products and sustaining the Wound Management product portfolio. As a new product development (NPD) core team member, the principal specialist works directly with the NPD team from the opportunity phase through commercialization. The principal specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide for Wound Management devices. Sustaining regulatory responsibilities include reviewing product labeling changes to ensure that regulatory requirements continue to be met, documenting “no file” decisions, reviewing promotional materials, and ensuring that our product technical documentation is current and accurate. This position is most suited for individuals with a broad background covering the total regulatory life cycle of medical devices and strong working knowledge and experience with reviewing advertising and promotional materials for medical devices.                     Responsibilities may include the following and other duties may be assigned. Provide regulatory affairs domain expertise and influence at all levels in support of the Wound Management device portfolio Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering both domestic and international regulations Prepare Pre-Sub and 510(k) submissions and 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 strategies and requirements and communicate that information to the business team Support international product registrations as needed Manage multiple projects and prioritize tasks on day by day basis to meet project schedules Collaborated with engineering, quality, clinical, marketing, and other functions to fulfill responsibilities Review promotional and advertising material Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards Create or revise departmental procedures to improve operations or to 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. Must Have:

Bachelor’s degree required Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.

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. 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. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are