Clinical Affairs Specialist

-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.

-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).

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.

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

-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.

-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.

-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.