IVD Documentation Scientist, Manufacturing and Medical Device (Contract)

We are seeking an experienced scientist who is a subject-matter expert in GMP reagent manufacturing under ISO 13485 and IVD medical device documentation. This role will be the key individual responsible for the manufacturing documentation required for a high risk IVD device meeting the rigor of FDA’s PMA and IVDR’s Class C/D submission including Specifications and Procedures for Manufacturing, Packaging, Storage, Handling, Distribution and Process Controls.  The focus will be working closely with the assay development, reagent manufacturing, regulatory, and quality teams to craft the procedures, templates, and documentation that govern high-quality reagent manufacturing execution, including batch records, CoAs, study plans, reports, SOPs, and design history file content.

What you’ll do

IVD documentation (Manufacturing and Medical Device)

• Author and revise existing reagent manufacturing and qualification procedures to ensure processes are repeatable and meet GMP and IVD quality documentation expectations including 21 CFR 820 and ISO 13485 requirements

• Author batch record templates and finalize batch manufacturing records (BMRs) for GMP reagent manufacturing processes, including incoming receipt, in-process, and release steps

• Develop Certificates of Analysis (CoAs) and specification documents for GMP-grade reagents, controls, and raw materials, aligned with regulatory expectations

• Write and maintain manufacturing study plans and summary reports for lot qualification, lot-to-lot variability, stability, and process characterization studies

• Draft and revise SOPs, work instructions, and manufacturing process descriptions for inclusion in the Device History Record (DHR) and Device Master Record (DMR)

• Develop and maintain Design History File (DHF) documentation packages to support PMA submission, including manufacturing development reports, risk assessments, and design transfer documentation, process validation, equipment and software qualification

• Compile and organize manufacturing evidence packages (batch records, qualification data, CoAs, validation reports) for regulatory submission

• Support other IVD documentation as needed, such as FMEA, BOMs, trace matrix 

CMO & Supplier Coordination

• Review CMO-generated documentation (batch records, CoAs, deviation reports)