Certified Diabetes Care and Education Specialist (CDCES) — Post-Market Surveillance

DEKA Research & Development • Manchester, NH

12d • Hybrid

About The Position

DEKA Research, on behalf of Millyard Advanced Medical Products is seeking a Certified Diabetes Care and Education Specialist (CDCES) to join our Post-Market Surveillance team. This role applies clinical diabetes expertise to the review, investigation, and disposition of patient reports related to the twiist insulin delivery system and the twiist Loop algorithm. The ideal candidate bridges clinical insulin therapy knowledge with regulatory complaint-handling processes to ensure patient safety and product quality. This is an on-site role with potential for hybrid; may require occasional travel for training, audits, or clinical collaboration.

Requirements

• Active Certified Diabetes Care and Education Specialist (CDCES) credential.
• 3+ years of clinical experience in diabetes management, with hands-on familiarity with insulin pumps and/or automated insulin delivery (closed-loop) systems.
• Strong understanding of insulin dosing principles, CGM integration, and AID algorithm behavior or a desire to gain expertise in these areas.
• Excellent analytical, writing, and documentation skills.

Nice To Haves

• RN, RD, RPh, PA, or other relevant clinical licensure preferred.

Responsibilities

• Review, triage, and investigate complaints involving the twiist insulin delivery system and twiist Loop algorithm, including device malfunctions.
• Assess complaint narratives from a clinical perspective, correlating reported symptoms/outcomes with insulin pump therapy, automated insulin delivery (AID) logic, and glycemic patterns.
• Determine whether complaints meet reportability criteria under MDR/FDA and applicable international vigilance regulations (e.g., EU MDR), in coordination with Regulatory Affairs.
• Partner with Engineering, Software, and Quality teams to correlate device data logs, CGM data, and algorithm behavior with reported patient/user experience.
• Document investigation findings, root cause analyses, and risk assessments in the complaint management system in compliance with 21 CFR 820.198 and ISO 13485.
• Identify trends or signals across complaint data that may indicate emerging safety issues, and escalate per CAPA and risk management procedures.
• Provide clinical insight during Health Hazard Evaluations (HHEs) and support Risk Management File updates.
• Gather and assess clinical details needed for thorough investigation, as needed.
• Contribute to labeling, training material, and design improvement recommendations based on complaint trends.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed