Position:
Regulatory Affairs Specialist
Company Description
Machaon Diagnostics, Inc. is an independent Clinical Reference Laboratory and Contract Research Organization/Clinical Trials Services founded in 2003 in Oakland, California. We specialize in coagulation and thrombosis, complement-mediated diseases, kidney disease, and rare disease genetics. Our mission is to save more lives with lab testing.
Role Description
This is a full-time on-site role for a Regulatory Affairs Specialist located in Berkeley, CA. The Regulatory Affairs Specialist will be responsible for handling regulatory documentation, ensuring regulatory compliance, understanding and meeting regulatory requirements, and preparing regulatory submissions.
Ensure Regulatory Compliance:
Monitor and ensure the lab complies with applicable federal, state, and local regulations (e.g., CLIA, CAP, FDA, CMS, HIPAA).
2. Manage Licensure and Accreditation:
Prepare, submit, and maintain licenses and accreditations for the lab across various states and regulatory bodies.
3. Prepare Regulatory Submissions:
Draft and submit documentation for new tests, instruments, or processes, especially for FDA (e.g., 510(k), EUA) or CMS notifications.
4. Audit Readiness and Support:
Coordinate and support internal and external audits, inspections, and assessments (e.g., CAP inspections, CLIA surveys).
5. Monitor Regulatory Changes:
Track evolving regulations, guidance documents, and industry standards to ensure proactive compliance.
6. Develop and Maintain Policies:
Create, review, and update SOPs, quality manuals, and regulatory policies to align with current requirements.
7. Cross-functional Communication:
Liaise with laboratory operations, quality, legal, and R&D teams to ensure regulatory alignment in product development and operational changes.
8. Train Staff on Compliance:
Educate lab personnel on regulatory requirements and updates through training programs and documentation.
9. Risk Assessment and Mitigation:
Identify regulatory risks in testing processes or business changes and help implement appropriate mitigation strategies.
10. Handle Product and Test Labeling/Claims:
Review and approve marketing, labeling, and test result claims to ensure regulatory accuracy and avoid misbranding.
Qualifications
- Regulatory Compliance and Regulatory Affairs expertise
- Experience with Regulatory Documentation and Regulatory Submissions
- Familiarity with Regulatory Requirements
- Strong attention to detail and organizational skills
- Ability to work effectively in a team and independently
- Advanced degree in a relevant field (e.g., Life Sciences, Regulatory Affairs)
- Certifications in Regulatory Affairs are a plus
- Device IVD experience is a plus