DELFI Diagnostics is seeking an experienced scientist to own GMP manufacturing documentation for high-risk IVD devices. You will craft batch records, CoAs, and SOPs, and maintain DHF/DMR content for PMA submissions. Collaboration with assay development, regulatory, and quality teams is essential.
The role requires hands-on GMP work, strong document control, and familiarity with 21 CFR 820 and ISO 13485. 1–2 in-office days weekly are available for eligible locations.
#J-18808-LjbffrIVD Documentation Scientist: GMP Manufacturing & Regulatory in palo alto at Unknown Company
This position is listed as full time and onsite.