Clinical Affairs Specialist (Onsite - Acton, MA)

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.