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Regulatory Affairs Consultant

2 months ago

New York, United States BioTalent Full time

A leading MedTech organisation are looking to add a Quality Assurance and Regulatory Affairs Consultant to their small team. The perfect candidate will be consulting on both Quality and Regulatory compliance issues and should have a problem solving attitude. 7 -10 years experience within the Medical Device industry is required, as is extensive experience with Class I - III devices and a range of global regulatory submission experience.


Responsibilities will include:

  • Regulatory submission experience 510k, PMA, DE Novo
  • Maintaining company Quality Management System
  • Liaising closely with FDA
  • ISO 13485 and ISO 14971
  • Support QA/RA Business Development
  • Post Market Surveillance


You will be working cross collaboratively with different teams to encourage business development. If you think you are a good fit for this role and the responsibilities align with your background, please apply to the job posting and we can discuss hourly rates.