Job Title: Specialist, Technical Documentation and Data Analysis
Job Description
The Technical Documentation and Data Analysis Specialist, plays a crucial role in supporting Research & Development and Regulatory Affairs by performing data analysis and authoring technical documentation for immunoassay in vitro diagnostic (IVD) products. This role involves contributing to design control documentation and regulatory submissions under IVDR and FDA frameworks, ensuring technical content is accurate, traceable, and compliant with applicable quality system requirements. This position is ideal for an early-career professional with hands-on experience in regulated environments looking to deepen expertise in assay data analysis and regulatory technical writing.
Responsibilities

+ Draft, revise, and maintain technical documentation including protocols, validation and verification reports, stability reports, design inputs, and other design control deliverables.

+ Ensure ...