The Regulatory Affairs Specialist IV position requires a high-level strategist, individual contributor and subject-matter-expert responsible for creating and executing regulatory strategies for pre- and post-market activities and managing complex issues that may have significant impact on the business. 

 RESPONSIBILITIES OF THE SENIOR REGULATORY AFFAIRS SPECIALIST:

• Providing pre- and postmarket regulatory initiatives for immunoassay devices, ensuring the development and implementation of these advanced and aggressive regulatory strategies provide a competitive.
• Author premarket submissions, including 510(k)s and PMA supplements to the U.S. FDA in alignment with pre-market strategies.
• Create / Manage Technical Files in compliance with IVDD and IVDR.
• Using knowledge of global regulatory requirements achieve strategies that focus on speed to market and successful submissions to obtain approval in an efficient timely manner.
• Ensure sound premarket product regulatory strategies include the timely and consistent review of post-market activities; such as adverse events and recall notification, minimizing the risk of negative premarket submission actions, including agency review delays.

 REQUIRMENTS OF THE SENIOR REGULATORY AFFAIRS SPECIALIST:

• Bachelor’s degree with 9+ years of experience OR Master’s degree with 7+ years of regulatory experience, preferably in areas of life sciences, engineering, or quality assurance. 
• Fifteen years of relevant experience in a regulated medical device/diagnostic industry.
• Subject matter expertise in regulatory affairs for medical devices and in vitro diagnostics.
• Experience in registration and commercialization of medical device and diagnostic products.
• Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean

 

DAVIS Companies partners with the top employers locally and nationally. They choose us because of our reputation for finding high quality talent, fast, but also our experience for evaluating and representing the best candidates in the marketplace.  We make every effort to provide updates and feedback to candidates at each stage of the process as we appreciate how stressful looking for a new role can be.  Apply today and experience “The DAVIS Difference”. 

#MON
#MINN-A