Regulatory Affairs Specialist

LeMaitre • Burlington, MA

3d • $90,000 - $110,000

About The Position

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.

Requirements

• Bachelor's degree from four-year college or university
• At least 3 years related experience in a regulatory role (medical device)
• Contributed to a 510k and/or CE Tech Files/Design Dossier
• Ability to read, analyze, and interpret general, professional journals, technical procedures, and regulations
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the regulators
• Fluent in English
• Ability/experience to understand scientific/technic aspects of the medical devices, preferentially for vascular devices

Nice To Haves

• RAC certified is a plus

Responsibilities

• Responsible for preparation of regulatory submissions, including FDA 510(K), CE Technical Documentations, Canadian Device Applications, etc.
• Contribute to the compliance to EU MDR 2017/745 project
• Review significant product submission issues and may negotiate submission issues with the regulatory agencies
• Provide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval
• Provide on-going support to product development teams for regulatory strategy and questions
• Review regulations and guidance to keep apprised of new regulatory developments
• Other responsibilities assigned by the management

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level