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
Junior 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
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical research experience, protocol design, regulatory submission support, cross-functional collaboration, GCP/ISO compliance, study file management
Preferred skills
Diabetes technology experience, wearable devices, human factors studies, new product development, Master's degree
Technologies
GCP, ISO 14155, FDA regulations, IDE, 510(k), PMA, CE filings
Responsibilities
Support development of clinical study strategies; assist in designing clinical protocols and consent forms; coordinate with external research sites; act as liaison between Clinical, Regulatory, Medical, and R&D teams; support preparation of clinical sections for regulatory submissions; monitor clinical activities for compliance; maintain clinical study files.
Seniority
Junior, hands-on IC