Regulatory Affairs Manager
North Haven, Connecticut, United States of AmericaAll locationsNorth Haven, Connecticut, United States of AmericaLafayette, Colorado, United States of AmericaMansfield, Massachusetts, United States of AmericaMounds View, Minnesota, United States of America On-site
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About the role
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 Lung Health and Gynecologic products within the Surgical organization. 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: Lafayette, CO; Mounds View, MN; North Haven, CT; or Mansfield, MA. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). 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 Lung Health and Gynecologic products within the Surgical organization. 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.
What you'll bring
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- Bachelor’s degree required.
- Minimum of seven years of relevant experience or an advanced degree with a minimum of five years of relevant experience.
- The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position
- they are not an exhaustive list of all the required responsibilities and skills of this position.
- For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile.
- The employee is also required to interact with a computer, and communicate with peers and co-workers.
- Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
- At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact.
- Five or more years of medical device regulatory affairs experience.
- Degree in engineering or an advanced degree.
- Proven track record of leading high-performing teams.