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QA / RA Manager

  • Sector: Medical Devices
  • Contact Email:
  • Job Ref: 17966

Excellent opportunity for Quality Assurance and Regulatory Manager to join a multinational Medical Devices company based in Frankfurt, Germany. This role is responsible for maintaining quality system processes and documentation in compliance with domestic and international regulatory/quality requirements.

Overview of your responsibilities (full job description available on request)

  • Assist in the development of quality system policy, procedures, and instructions.
  • Assist Director, Quality Assurance with the management of multiple QMS functions
  • Oversees the Quality Management System in EU
  • Audits and collaborates with outsourced processes in the EU/Internationally
  • Manages external and internal audits.
  • Oversee EU/International complaints.
  • Performs investigations of EU related CAPA's, non-conformances and customer complaints.

Knowledge, Skills and Experience Required for the Role:

  • BS in Engineering or Life Science Field required.
  • 5-10 years of QA/RA experience in a regulated environment (e.g., ISO 13485:2016, 21 CFR Part 820 and MDSAP)
  • Trained ISO 13485:2016 auditor preferred.
  • Knowledge of European Medical Device Regulations and ISO Standards
  • Proficient in German and English

For a confidential discussion and more information on the role contact Courtney Russell

+353 (0) 71 9108062