Metric Bio
Director of Regulatory Affairs
Metric Bio is looking for an experienced Regulatory Affairs leader to develop and execute regulatory strategies for digital pathology products, imaging devices, and AI/ML-based medical software.
Responsibilities
- Develop and execute regulatory strategies for digital pathology products, imaging devices, and AI/ML-based medical software.
- Lead U.S. FDA submissions including 510(k), De Novo, PMA, Q‑Sub meetings, responses, amendments, and technical documentation.
- Prepare regulatory documentation, including design dossiers, device master files, labeling, clinical evaluation reports (CERs), and risk management files.
- Serve as the primary liaison with the U.S. FDA and participate in pre‑submission meetings, inspections, and audits.
- Oversee global regulatory preparation and submissions (EU MDR/IVDR, Canada, Australia, APAC as applicable).
Clinical Affairs
- Develop and execute clinical strategies for U.S. and global product validation.
- Oversee clinical study design, IRB submissions, site selection, investigator management, CRO coordination, enrollment tracking, and study governance.
- Lead clinical data collection, clinical evaluation reports, safety assessments, and post‑market clinical follow‑up activities.
- Ensure compliance with Good Clinical Practice (GCP), clinical regulations, and applicable global standards.
Compliance & Cross‑Functional Leadership
- Ensure adherence to ISO 13485, ISO 14971, IEC 62304, IEC 60601, FDA QSR (21 CFR 820), and SaMD guidance.
- Provide regulatory input to product development, risk analysis, labeling, market claims, and change management.
- Support Quality Assurance activities, including inspection readiness, CAPA, internal audits, and regulatory documentation.
- Collaborate closely with R&D, Quality, Product Management, and Operations teams across global locations.
Required Qualifications
- Bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field (Master’s preferred).
- 8–10 years of experience in U.S. medical device or diagnostics regulatory affairs and clinical affairs.
- Experience with digital pathology, imaging systems, diagnostics, or Software as a Medical Device (SaMD).
- Strong understanding of global regulatory frameworks, including EU MDR/IVDR, Health Canada, and TGA.
- Demonstrated leadership experience managing regulatory teams or complex cross‑functional initiatives.
Preferred Qualifications
- RAC (Regulatory Affairs Certification).
- Experience with AI/ML‑enabled diagnostic products.
- Experience leading global, multi‑site clinical trials.
- Knowledge of cloud‑based digital diagnostic platforms.
Seniority Level
- Director
Employment Type
- Full‑time
Job Function
- Other
Industries
- Hospitals and Health Care
Location: San Jose, CA
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