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Senior Regulatory Affairs Specialist

3 months ago

Waltham, United States EPM Scientific Full time

Title: Senior Regulatory Affairs Specialist


The Senior Regulatory Affairs Specialist will be responsible for:

  • Lead preparation for global and US submissions such as 510k and IVD/IVDR related products
  • Handle pre and post market submissions
  • Manage all aspects of IVDD/IVDR requirements
  • Lead Health Canada and international device licensing
  • Support new product submissions
  • Support product technical file development and maintenance


Qualifications:

  • MUST HAVE 2+ years of Regulatory experience in the IVD space
  • Previous experience with 510k submissions, Health Canada, International Device Submissions Licensing and Registration experience
  • Knowledge of IVDD/IVDR
  • Quality system auditing experience preferred
  • CQA and RAC certifications preferred