CDCES: Post-Market Safety & Investigations Lead

DEKA Research and Development; Manchester (NH); Hybrid; USD 110,000 - 150,000; Full time

Job summary

DEKA Research & Development is seeking a Certified Diabetes Care and Education Specialist (CDCES) to join our Post-Market Surveillance team in Manchester, NH. The role focuses on reviewing complaints related to insulin delivery systems, correlating clinical data, and ensuring compliance with MDR and ISO standards.

Ideal candidates have 3+ years of diabetes management experience, insulin pump familiarity, and a strong capability in clinical documentation.

Qualifications

• Active CDCES credential required.
• 3+ years of clinical diabetes management experience with insulin pumps or closed-loop systems.
• Strong understanding of insulin dosing, CGM integration, and AID algorithm behavior.

Responsibilities

• Review, triage, and investigate complaints involving insulin delivery systems and AID algorithms.
• Assess complaint narratives from a clinical perspective, correlating symptoms with therapy and glycemic patterns.
• Determine reportability criteria under MDR/FDA and EU MDR with Regulatory Affairs.
• Collaborate with Engineering, Software, and Quality teams to correlate data logs with patient experience.
• Document investigation findings, root cause analyses, and risk assessments in the CAPA system per 21 CFR 820.198 and ISO 13485.
• Identify trends across complaint data indicating emerging safety issues and elevate per CAPA procedures.
• Provide clinical input during Health Hazard Evaluations and support Risk Management File updates.
• Gather clinical details needed for thorough investigation as needed.
• Contribute to labeling, training material, and design improvement recommendations based on trends.

Skills

CDCES credential

Clinical diabetes management

Regulatory complaint handling

Documentation & writing

Education

RN licensure preferred

Job description

DEKA Research & Development is seeking a Certified Diabetes Care and Education Specialist (CDCES) to join our Post-Market Surveillance team in Manchester, NH. The role focuses on reviewing complaints related to insulin delivery systems, correlating clinical data, and ensuring compliance with MDR and ISO standards.

Ideal candidates have 3+ years of diabetes management experience, insulin pump familiarity, and a strong capability in clinical documentation.