Regulatory Affairs Manager, Medical Device
Location: United States,
Our client is a unique, global Medtech company with a rich history of success in the areas of Advanced Wound Care, Ostomy, Critical Care, and Infusion with close to 10,000 employees worldwide. They are in a new growth stage with incredible, disruptive technology that will bring great value in improving patient lives. Our client is expanding its current portfolio with advanced technology that includes software development, and SaMD. We are partnering to help bring on a Regulatory Affairs Manager to oversee RA submissions, RA global strategy, and mentor and lead a team of RA professionals. This leadership position will ensure regulatory compliance for product categories, change controls, labeling, sales & marketing collateral oversight, and be involved in providing regulatory insight and direction to other business units NPD, NPI, and product lifecycle.
The Right Talent:
BS in a relevant degree
7+ Years of RA or Quality experience in the Medtech industry
1+ year of leadership experience with direct reports
Experience interacting with the FDA and governing bodies
Experience with RA submissions- 510 (k), De Novo, EU MDR, etc.
Project Management experience leading teams cross-functionally
Understanding of US and EU pathways for regulatory submissions
Ability to travel as needed: 0-25%
Strong communication and problem-solving ability
Remote with some travel
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