CDCES: Diabetes Device Post-Market Safety Lead

DEKA Research and Development; Manchester (NH); On-site; USD 95,000 - 115,000; Full time

Job summary

DEKA Research and Development, located in Manchester, NH, seeks a Certified Diabetes Care and Education Specialist to join our Post-Market Surveillance team. The role applies clinical diabetes expertise to review, investigate, and disposition patient reports related to the twiist insulin delivery system and twiist Loop algorithm.

The ideal candidate bridges clinical diabetes therapy with regulatory complaint handling to ensure patient safety and product quality.

Qualifications

• Active CDCES credential required.
• RN/RD/RPh/PA or other clinical licensure preferred.
• 3+ years of diabetes management experience with insulin pumps or closed-loop systems.
• Strong understanding of insulin dosing, CGM integration, and AID algorithm behavior or willingness to gain expertise.
• Excellent analytical, writing and documentation skills.

Responsibilities

• Review, triage, and investigate complaints involving the twiist insulin delivery system and twiist Loop algorithm.
• Assess clinical narratives and correlate with insulin therapy and glycemic patterns.
• Determine reportability criteria under MDR/FDA and international regs in coordination with Regulatory Affairs.
• Partner with Eng, Software, and Quality to correlate device data logs with user experience.
• Document investigations, root cause analyses, and risk assessments per 21 CFR 820.198 and ISO 13485.
• Identify trends in complaints and elevations per CAPA and risk management.
• Provide clinical input during Health Hazard Evaluations and support Risk Management File updates.
• Gather clinical details needed for thorough investigations.
• Contribute to labeling, training material and design improvements based on trends.

Skills

Clinical diabetes management

Insulin pumps familiarity

Analytical writing

Documentation

Education

RN license

RD license

RPh license

Job description

DEKA Research and Development, located in Manchester, NH, seeks a Certified Diabetes Care and Education Specialist to join our Post-Market Surveillance team. The role applies clinical diabetes expertise to review, investigate, and disposition patient reports related to the twiist insulin delivery system and twiist Loop algorithm.

The ideal candidate bridges clinical diabetes therapy with regulatory complaint handling to ensure patient safety and product quality.