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

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.

How you will make an impact as a CDCES – Post Market Surveillance:

• 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 you need to be successful:

• Active Certified Diabetes Care and Education Specialist (CDCES) credential.
• RN, RD, RPh, PA, or other relevant clinical licensure preferred.
• 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.

About Millyard Advanced Medical Products:
https://millyardadvanced.com/
Located in the heart of the Regen Valley in Manchester, NH, our company aims to positively influence the healthcare landscape.

Established 2019

Selected Partners:
Contract Designer: DEKA Research & Development
Contract Manufacturer: Merrimack Manufacturing
About DEKA:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.

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