Global Regulatory Affairs Manager — Medical Devices (Onsite)

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

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.