This long-term contract role serves as a Project Coordinator within the Product Change Control team of a leading biotechnology company in Foster City, California. The position focuses on managing the commercial lifecycle of drug-device combination products by initiating and closing change control records for manufacturing and process updates. Key duties include maintaining risk management documentation, coordinating post-market surveillance reports, and supporting complaint investigations alongside cross-functional partners like Engineering and Quality. The role appeals to professionals seeking to work with world-class life sciences organizations while ensuring regulatory compliance with FDA and ISO standards. Candidates will gain valuable experience in design controls and quality systems within a collaborative environment that prioritizes product safety and supply continuity.