Sr. Specialist, Regulatory Affairs

Job description

Overview This is an exciting opportunity to join LeMaitre Vascular's Regulatory Affairs team. We are seeking someone looking for a role where they can have a real impact while building their capabilities and growing their career. In this role, the candidate will be responsible for developing and implementing documentation policies and practices that comply with US and International regulatory agencies with respect to vascular device products. Candidate will prepare regulatory submissions for new products/product changes to ensure timely approval for market release and will follow up with regulatory agencies on these submissions. Candidate will serve as regulatory affairs representative to product development teams to provide guidance on regulatory issues and filing activities. Candidate will be responsible for producing document packages for regulatory submission (including 510(K), CE Technical Documentations, Canada Device Applications, etc.) and will review documents that may impact regulatory submissions/approvals. Responsibilities: The Sr. Specialist, Regulatory Affairs will report to the VP of Regulatory Affairs and have the following primary responsibilities: Pay range $95,00...