Regulatory Product Manager

Regulatory Product Manager
In Milwaukee, Wisconsin 53224

Job Description

Workway is a professional staffing firm, working with organizations across the country to place exceptional candidates. We are looking for a Regulatory Product Manager responsible to provide support for requests for regulatory-related documentation and aid in resolution of issues requiring regulatory review/oversight.  

Your specific duties will include:

  • Prepare and submit applications, associated documentation and equipment to required agencies including, but not limited to Health Canada License applications, FDA 510(k) or PMA, Australia TGA, EU Notified Bodies, etc
  • Communicate with agencies to address questions and issues that arise during and after product evaluations. o Log and organize registration certificates received. o Maintain up-to-date records of registration activities. o Maintain the Medical Device Listings for assigned products. o Analyze and track world-wide product registrations
  • Periodic review of regulations and standards versus technical file contents to ensure continued compliance. Take action to remedy any deficiencies identified

Specific qualifications for the position include

  • High Scho0l diploma or Equivalent

Let one of our recruiters assist you in finding and preparing for interviews with our clients. Whether you are interested in a direct hire, temp-to-hire, or temporary position, Workway can help you to put your best foot forward. Contact us today! 

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Abhijeet Pathak
abhijeet.pathak@workway.com
703-889-6814