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InsuletClinical Affairs Specialist (Onsite - Acton, MA)
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Before you apply
SalaryNo pay range posted
LocationUS - Massachusetts (Acton - Office)
Work modeon-site
SeniorityMid
DepartmentClinical Affairs
Company size1,001–5,000 people
PostedSep 21, 2026 · 1mo ago
Verified live3d ago
About the role
Job Summary
The Clinical Affairs Specialist will play a critical cross functional‑ role within Insulet’s Next Generation Platform (NGP) organization. This position is responsible for supporting clinical strategy, evidence generation activities, and product development efforts that bridge Clinical Affairs, Regulatory Affairs, Medical Affairs, and R&D.
The ideal candidate will bring experience in clinical research within medical devices—preferably diabetes, drug delivery, or wearable technologies—and thrive in a highly collaborative, fast paced‑ environment focused on bringing innovative products to market.
Key Responsibilities
Clinical Strategy & Evidence Generation
-Support the development of clinical study strategies for new and innovative product concepts.
-Assist in designing clinical protocols, informed consent forms, risk analyses, and related study documents.
-Contribute to clinical evidence plans that support regulatory submissions, product claims, and post‑market needs.
-Coordinate with external clinical research sites, investigators, and vendors as needed.
Cross Functional‑ Collaboration
-Act as an operational and scientific liaison between Clinical Affairs, Regulatory Affairs, Medical Affairs, and R&D, ensuring alignment of clinical requirements within product development timelines.
-Participate in design reviews and cross functional project team meetings to represent‑ clinical considerations (user safety, human factors, clinical risks, evidence requirements).
-Provide clinical input into product specifications, risk assessments, and verification/validation plans.
Regulatory & Medical Support
-Support preparation of clinical sections for regulatory submissions (e.g., IDE, 510(k), PMA, CE filings), including literature summaries, clinical data narratives, and review of technical documentation.
-Assist with the creation of medically accurate materials for labeling, training, and customer-facing communications.
-Partner with Medical Affairs to support real-world evidence generation, postmarket studies, and clinician insights related to new product concepts.