Clinical Affairs Specialist (Onsite - Acton, MA)
Core
Support clinical strategy, evidence generation, and product development for medical devices, bridging Clinical, Regulatory, Medical, and R&D functions.
Role type
Clinical Affairs Specialist (Medical Devices)
Builds
Clinical study strategies, protocols, regulatory submission documents, and evidence plans for new product concepts.
Domain
Medical Devices / Diabetes Technology / Drug Delivery
Required skills
Clinical research experience, protocol design, regulatory submission support, cross-functional collaboration, GCP/ISO compliance, study file management
Preferred skills
Diabetes technology experience, infusion systems, wearable devices, human factors studies, new product development, regulatory submission experience, Master's degree
Technologies
GCP, ISO 14155, FDA regulations, IDE, 510(k), PMA, CE filings
Responsibilities
Develop clinical study strategies and design protocols; coordinate with external research sites and vendors; act as liaison between Clinical, Regulatory, Medical, and R&D teams; support regulatory submissions and labeling materials; monitor clinical activities for compliance; maintain clinical study files.
Seniority
Junior to Mid-level, hands-on IC