Senior Manager Regulatory Affairs

Senior Manager Regulatory Affairs - (Medical Device) - Hybrid in MN

Our client is an, looking for a Senior Manager Regulatory Affairs with extensive experience with 510(k) submissions. As the Senior Manager Regulatory Affairs you will be the liaison for communication with US and international regulatory agencies for multiple submissions across the company.

Your main responsibilities will be:

Proposing, developing and implementing regulatory policies and strategies

Managing and mentoring a small team of specialists and consultants at various levels

Preparing and submitting EU technical files, Domestic IDE's, 510(k)s, Pre-Market Approval (PMA) Applications and other regulatory submissions

Leading meetings and building relationships with FDA and notified bodies

Assisting with internal and external audits

Representing the Regulatory Affairs department in interactions Quality, R&D, Commercial and other departments

Minimum qualifications include:

8+ years experience in Regulatory Affairs in the Medical Device industry

The successful candidate will have experience in the preparation, assessment, and submission of regulatory filings in the U.S. and preferably experience in European and/or Canadian submissions

A team player who can work flexibly and enthusiastically within a small business environment

Strong experience with FDA device regulations and regulatory submissions in North America and Europe

Leadership, influence, and negotiation skills with the ability to build collaborative relationships