Regulatory Affairs Specialist

This company is a well-established medical device company located in the Salt Lake Valley. As a Regulatory Affairs Specialist, you will manage the following areas:

• Supporting product development teams
• Assisting in preparing submissions including 510(k)’s, CE-Mark Dossiers, CE-Mark Technical files, and international dossiers.
• Assist in developing the regulatory strategy for project teams
• Providing input on and reviewing protocols and reports for design verification and design validation.
• Regulatory reviews of labeling content, product and process changes, and product documentation and promotional materials.

Basic Requirements:

• Post-market surveillance clinical research or clinical affairs
• Two or more years of regulatory affairs experience in medical devices
• Both domestic and international regulatory affairs
• it is best that you already what needs to be done in the area of regulatory affairs.
• Class II product experience

This is an on-site position. There exists the possibility for some hybrid-work setups.

You will enjoy a supportive group of very experienced people while pursuing your objectives. This is an opportunity to create some accomplishments beyond the usual regulatory scope. Apply to learn more!

About Us

We're the professional search consultants of Bruce & Associates. We assist companies in finding the professionals that propel them to new levels of organizational excellence.

Not sure this is right for you? If you have the basic qualification, yet are uncertain about this position, go ahead and send your contact information and ask for a confidential opinion. We do not refer candidates' information without their prior and enthusiastic approval.