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
- Quality, Quality Assurance, Regulatory, Regulatory Affairs, Research/Documentation
- Required Education
- Bachelors Degree
- Position Type
- Full time
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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