Clinical Affairs Specialist (Onsite- Acton, MA)

Insulet Corporation

1d•$76,400 - $114,575•Onsite

About The Position

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.

Requirements

Bachelor’s degree in a scientific, biomedical, or engineering field.
1-2 years of experience in Clinical Affairs, Clinical Research, or a related role within the medical device, biotech, or pharmaceutical industry.
Strong communication and collaboration skills with the ability to work effectively across diverse technical and clinical functions.
Ability to manage multiple priorities in a fast paced innovation environment.

Nice To Haves

Experience with diabetes technologies, infusion systems, wearable devices, or human factors studies.
Previous work in a new product development or innovation-focused setting.
Experience supporting regulatory submissions for medical devices.
Master’s degree in a relevant scientific or clinical discipline.

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 postmarket 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.
Clinical Operations & Documentation Support operational execution of feasibility, formative, summative, or early phase clinical studies.
Monitor clinical activities to ensure compliance with GCP, ISO 14155, FDA regulations, and internal quality procedures.
Maintain accurate and complete clinical study files and support audit readiness across assigned projects.