Regulatory Affairs Manager

Our mid sized medical device client is adding a Manager Regulatory Affairs to the team. The Manager ensures compliance with applicable laws and regulations in the development, manufacturing, and marketing of products and its subsidiaries’ products, and uses this knowledge to support pre-market and post-market activities and will work closely with Quality Assurance, Clinical Affairs, Sales and Marketing, Engineering, and Manufacturing for compliance to regulations.

Your role with the company:

Manage the daily operations of the Regulatory Affairs, including:

Management of 3 Regulatory Affairs Specialists

Oversee and prepare domestic and international regulatory submissions.

Prepare and review 510(k) and PMAs and PMA supplements for new and current products.

Provide guidance and oversight to team members related to regulatory compliance.

Provide regulatory input to companies design teams for the development of new products or procedures.

Support inspections by FDA, notified body, and other regulatory agencies.

Desired Profile:

Bachelor’s Degree with at least 5-8 years of related Regulatory experience, mostly in medical devices.

1+ years’ experience in a Regulatory Affairs management role.

Extensive knowledge of global medical device regulations and standards, such as, but not limited to FDA, MDD, EU MDR, Health Canada, Australia, Japan etc.