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

DEKA Research & Development
Manchester
Workplace: OnsiteFull timeFunction: Product ManagementExperience: 3+ yearsSkills: ["Analytical skills","Writing skills","Documentation","Clinical judgment","Risk awareness"]

Use clinical diabetes expertise to review, triage, and investigate post-market complaints for the twiist insulin delivery system and twiist Loop algorithm. Partner with Regulatory Affairs and engineering teams to correlate complaint narratives with insulin pump therapy, CGM data, and AID logic. Determine MDR/FDA reportability, document investigations, root cause analyses, and risk assessments, and support CAPA, HHEs, labeling updates, and risk management file maintenance.

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DEKA Research & Development
DEKA Research & Development
1 day ago

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

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Source: Company careers pageValidated by: Fursa AI
Last checked: 8 hours agoStatus: Live

Job Summary

Use clinical diabetes expertise to review, triage, and investigate post-market complaints for the twiist insulin delivery system and twiist Loop algorithm. Partner with Regulatory Affairs and engineering teams to correlate complaint narratives with insulin pump therapy, CGM data, and AID logic. Determine MDR/FDA reportability, document investigations, root cause analyses, and risk assessments, and support CAPA, HHEs, labeling updates, and risk management file maintenance.
Location: Manchester
Workplace: Onsite
Employment Type: Full time
Job Function: Product Management
Seniority: Mid level

Key Responsibilities

  • •Review, triage, and investigate complaints involving the twiist insulin delivery system and twiist Loop algorithm, including device malfunctions.
  • •Assess complaint narratives against reportability criteria under MDR/FDA (in coordination with Regulatory Affairs).
  • •Correlate reported symptoms/outcomes with insulin pump therapy, CGM data, and AID algorithm behavior; partner with Engineering, Software, and Quality.
  • •Document investigation findings, root cause analyses, and risk assessments in the complaint management system (21 CFR 820.198, ISO 13485).
  • •Identify safety trends/signals, escalate per CAPA and risk management procedures, and support HHEs and Risk Management File updates.
Travel: Low travel

Key Requirements

  • •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, including 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 willingness to build expertise).
  • •Excellent analytical, writing, and documentation skills for complaint investigations and reporting.
Experience:3+ yearsDiabetesMedical devices
Skills:Analytical skillsWriting skillsDocumentationClinical judgmentRisk awareness
Licenses:RNRDRPhPA
Certifications:CDCES
Tech Stack:MDREU MDRFDA21 CFR 820.198ISO 13485CAPACGMAutomated insulin delivery (AID)Closed-loop systemsInsulin pumpsTwiist insulin delivery systemTwiist Loop algorithm

Company Brief

DEKA Research & Development
DEKA Research & Development is a private R&D and product development firm founded by Dean Kamen that designs and manufactures medical devices, mobility systems, energy and water solutions, and low-volume production prototypes for healthcare and industrial customers.
Industry: Medical Devices
Company Size: Large (251 to 1,000 employees)
Growth: Established Company
Headquarters: Manchester, United States
Founded: 1982
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