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.

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.

Qualifications

Required

-Bachelor’s degree in a scientific, biomedical, or engineering field.

-1 to 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.

Preferred

-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.

Key Competencies

-Cross-functional influence—comfortable translating clinical needs to technical teams and vice versa.

-Detail orientation with a strategic mindset—capable of supporting both tactical study execution and long-term evidence planning.

-Strong analytical and critical thinking skills—able to interpret data and articulate clinical impact.

-Comfort with ambiguity and innovation—thrives in early-stage, exploratory product development.

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite

Additional Information:

Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $76,400.00 - $114,575.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.