Regulatory Affairs Manager

BioCT Innovation Commons; North Haven (CT); On-site; USD 150,000 - 190,000; Full time

Job summary

Medtronic is seeking a Regulatory Affairs Manager to establish strategies for worldwide product approval and submission activities, focusing on U.S. and EU compliance within the Surgical Operating Unit. The role requires hands-on leadership and collaboration with cross-functional partners to align regulatory plans with business objectives.

The position requires onsite work four days per week at our Surgical locations: North Haven, CT (preferred), Lafayette, CO, Mounds View, MN, or Mansfield, MA.

Qualifications

• Experience in regulatory affairs for medical devices
• Leadership and cross-functional collaboration skills
• Strong understanding of U.S. FDA and EU regulations

Responsibilities

• Lead regulatory strategies for new and existing medical devices to support business goals.
• Oversee day-to-day regulatory activities and potentially manage team members.
• Collaborate with external authorities and cross-functional partners to ensure global product approval.
• Develop and translate regulatory strategies into actionable work plans for Regulatory Affairs teams.

Job description

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