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Senior Manager – Regulatory Affairs & Quality Assurance

Affimedix Inc
3556 Investment Blvd, Hayward, CA 94545
Highly competitive package commensurate with experience. In401(k), Health insurance, Paid time off
Start date
Mar 19, 2023

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Affimedix, a fast-growing Medical Device company in Silicon Valley of California, focuses on R & D, product design, development, manufacturing and marketing of its “Proprietary” Point-Of-Care Health Diagnostics globally. Affimedix is redefining Point-Of-Care Diagnostics for small molecule biomarkers using its game-changer Immuno-Sandwich Test technology.




  • Interface with external regulatory authorities for audits, inspections and other inquiries within the scope of applicable ISO, IVDR, MDR, FDA and product safety standards.
  • Lead FDA, ISO internal and external audit activities.
  • Serve as the Management Representative for company’s Quality Management System (QMS) for in vitro Diagnostics.
  • Develop an effective Document Control Management system, including relevant Standard Operating Procedures (SOPs) and Work Instructions (WIs).
  • Work closely with internal departments and external Consultant to support resolutions of nonconformances, CAPA and supplier corrective action requests.
  • Strengthen quality awareness throughout the organization, support technical services and process improvements.
  • Interface with R&D, Production and Marketing to ensure that products are developed and produced according to applicable regulations and standards.
  • Coordinate product registrations in different countries.
  • Maintain database for the worldwide regulatory status of products.

Qualifications & Critical Requirements:


  • Minimum BS in Biology or a related Life Sciences field; Advanced degree in science Preferred.
  • Minimum 10 years of experience in Quality Assurance Management / Regulatory Affairs in the in vitro Diagnostics / medical device industry.
  • Experience of ISO 13485: 2016, IVDR, MDR, 21 CFR 803, 806, 820, and all applicable requirements and regulations to support the manufacture and marketing of medical devices is preferred.
  • Ability to prioritize tasks in a fast-paced environment.
  • Strong written and oral communication skills required.

For the right leader, this is a wonderfully rewarding role with tremendous growth prospects. If you are qualified and think you're a strong fit for this role, please apply ASAP.


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