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Regulatory Affairs Manager

2 months ago

New York, United States X4 Life Sciences Full time

A dynamic class II Medical Device client of X4 Life Sciences are looking for a skilled Regulatory Affairs Manager to join their team. With a range of new products launching this company are looking for a hands-on team leader who can maintain compliance to international medical device regulations.


Responsibilities include:

  • Maintain global regulations US, EU, ISO and MDSAP
  • Authoring 510k's
  • Leading company documentation
  • Risk Management, Supporting SOPs, MDR transition
  • Work closely with Quality and Engineering teams


Required:

  • 7 years' in Regulatory
  • Management experience
  • Science related education


If you are interested in hearing more about this position, please apply to the job posting.


If someone in your network is a good fit, please send across their details. We offer a generous referral fee upon the successful placement of candidates.