CDCES – Post-Market Safety Lead, Insulin Delivery (Hybrid)

DEKA Research & Development; Manchester (NH); Vor Ort; USD 70.000 - 90.000; Vollzeit

Zusammenfassung

DEKA Research & Development is seeking a Certified Diabetes Care and Education Specialist (CDCES) to join our Post-Market Surveillance team in Manchester, NH. This on-site role may hybrid and involves reviewing complaints related to the twiist insulin delivery system and Loop algorithm, with emphasis on patient safety and product quality.

You will collaborate with Regulatory Affairs, Engineering, Software, and Quality to assess narratives, correlate device data, and document investigations in

Qualifikationen

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

Aufgaben

• Review, triage, and investigate complaints involving insulin delivery systems and loop algorithm.
• Assess narratives clinically, correlating symptoms with insulin pump therapy and CGM data.
• Determine reportability under MDR/FDA and international vigilance regulations.
• Collaborate with Engineering, Software, and Quality to correlate device data and logs.
• Document findings in the complaint management system per 21 CFR 820.198 and ISO 13485.
• Identify trends and elevate per CAPA and risk management procedures.
• Provide clinical insight for Health Hazard Evaluations and Risk Management updates.
• Gather clinical details needed for thorough investigations.
• Contribute to labeling, training material, and design improvements from trends.

Kenntnisse

Analytical thinking

Documentation

Clinical writing

Regulatory familiarity

Ausbildung

CDCES credential

RN/RD/RPh/PA licensure preferred

Jobbeschreibung

DEKA Research & Development is seeking a Certified Diabetes Care and Education Specialist (CDCES) to join our Post-Market Surveillance team in Manchester, NH. This on-site role may hybrid and involves reviewing complaints related to the twiist insulin delivery system and Loop algorithm, with emphasis on patient safety and product quality.

You will collaborate with Regulatory Affairs, Engineering, Software, and Quality to assess narratives, correlate device data, and document investigations in