Senior Technical Specialist

Our client is seeking a Senior Technical Specialist to join their team in Foster City, CA. This role is primarily onsite, with a hybrid schedule of three days per week in the office. The Senior Technical Specialist will play a critical role in coordinating and managing change control records for combination products, overseeing the initiation, routing, and closure of change records related to product, manufacturing process, and design development. The position is also responsible for managing test sample builds—including procurement and logistics—coordinating post-market surveillance reports, updating risk management files, and supporting complaint investigations. The ideal candidate will have a strong background in medical device development and/or pharmaceutical operations within a cGMP environment, excellent organizational and project management skills, and a solid understanding of US, EU, and international medical device and pharmaceutical regulations. Experience with Veeva Vault and the ability to collaborate with cross-functional teams, vendors, suppliers, and contract manufacturers is essential.