Regulatory Affairs Specialist

4 days ago


San Diego, California, United States CorDx Full time

At CorDx, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for assisting in the preparation, compilation, submission, and maintenance of regulatory filings and registrations, including DeNovo and 510(k) submissions for IVD products.

The ideal candidate will have a strong understanding of regulatory guidelines and product development life cycles. They will work closely with R&D, quality assurance, and manufacturing teams to obtain required documentation in compliance with regulatory requirements.

Key responsibilities will include:

  • Assisting in the preparation and submission of regulatory filings and registrations
  • Maintaining and organizing regulatory documentation
  • Providing administrative and project support to the Regulatory Affairs team
  • Supporting internal audits and maintaining compliant regulatory documentation

Requirements include a Bachelor's degree in biology, chemistry, regulatory affairs, or a related field, and ~2+ years of experience in regulatory affairs, preferably in the IVD or medical device industry.

We offer a competitive salary, medical insurance plan, retirement plan, and training & development opportunities.

CorDx is an equal-opportunity employer and celebrates diversity, recognizing that diversity of thought and background builds stronger teams.



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