Regulatory Product Manager
In Milwaukee, Wisconsin 53224
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!