Hiring: Principal Regulatory Affairs Company: Medtronic Location: North Haven, CT Job Posted Time: 2026-09-16 14:45:18 About the job Experience: •7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience. Required Skills: •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 Qualifications: •Operational 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. •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 not an exhaustive list of all the required responsibilities and skills of this position. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!