Regulatory Affairs Manager

We anticipate the application window for this opening will close on - 4 Nov 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 As the Regulatory Affairs Manager, you will be responsible for establishing strategies for worldwide product approval and submission activities, directly executing submission activities focused on the U.S. and EU, and ensuring regulatory compliance for products within the Surgical Operating Unit. The Regulatory Affairs Manager is expected to achieve results through hands-on leadership and the delegation of responsibilities to individual contributors. This role requires collaboration with business partners to develop regulatory strategies that support business goals and translate those strategies into work plans for the Regulatory Affairs teams. This position requires working onsite four days per week at one of our Surgical locations: North Haven, CT (preferred), Lafayette, CO, Mounds View, MN or Mansfield, MA.                     Responsibilities may include the following, as well as other duties that may be assigned. • May serve as the regulatory lead for one or more new product development projects. • Oversee the day-to-day regulatory activities of the Stapling Regulatory Affairs team, with the potential to assume direct people management responsibilities as business needs evolve. • Become actively involved in daily operations to meet schedules or resolve complex problems. • Develop regulatory strategies for existing, new, and modified medical devices to meet business objectives, and collaborate across a matrixed organization to ensure the global success of products. • Collaborate with external regulatory authorities and cross-functional stakeholders to ensure alignment of regulatory strategies with business objectives. • Lead interactions with regulatory agencies as part of strategy development and the support of regulatory reviews. • Provide guidance on regulatory requirements necessary for contingency planning and ensure compliance with all applicable regulations. • Partner with quality, engineering, clinical, manufacturing, and commercial teams to ensure regulatory compliance throughout the product lifecycle. • Manage team performance, resource planning, talent development, succession planning, and employee engagement initiatives. • Provide oversight of regulatory reviews of advertising and promotional materials to ensure that product claims and materials align with applicable local guidance and regulations. • Sponsor and actively monitor a high-performance management culture where employees have clear performance expectations. • Provide targeted career coaching and feedback; manage and develop team members at all levels of experience. • Clearly identify and communicate talent differentiation, and ensure that development actions and rewards align accordingly. • Conduct timely and candid performance evaluations and support meaningful development activities. • Cultivate a safe, inclusive, and engaging work environment. • Provide periodic progress reports or presentations to senior management regarding OU product submission goals. • Continuously improve operating mechanisms, communication pathways, and processes to increase efficiency. • Direct or perform the coordination and preparation of document packages for regulatory submissions, internal audits