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