Regulatory Affairs Manager

Company: Bruce & Associates
Location: Draper
Posted on: April 1, 2025

Job Description:

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

• Developing and implementing regulatory strategies
• Developing regulatory pathway plans for new and existing products.
• Maintaining proficiency in worldwide regulatory requirements
• Working with product development, operations, distribution, and other experts to resolve RA issues.
• Create more efficiencies in the RA process.Basic Requirements
  
  • Ten or more years experience in regulatory affairs of medical devices
  • Extensive understanding of ISO 13485, ISO 14971, QSR, MDR
  • Five or more years of experience with orthopedic devices
  • Desired: CQE, CM Q/QE
  • Desired: quality auditing experience
  • Desired: post-market surveillance techniques
    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.
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Keywords: Bruce & Associates, Draper , Regulatory Affairs Manager, Executive , Draper, Utah