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The QA and Regulatory Affairs Manager will play a fundamental role in maintaining continued regulatory compliance with standards andmedical device regulations. The ideal candidate will join a dynamic team launching innovative technology.
Client Details
My client is an established medical device business with a small team based in London. They currently have a device approval in Europe and is currently expanding to other regions including USA. Looking for a Regulatory Affairs Manager - RA/QA to join the high performing team.
Description
Regulatory Affairs Manager - RA/QA
Main duties include :
- QMS management
- Responsible for management and planning of the internal audit programme and conducting internal audits
- Post-Market Surveillance activities
- MDR, FDA planning and implementation and regulatory support for other regions
- Review of technical files, Risk Management and GSPR
Profile
- University degree in relevant life science, scientific or engineering-based discipline
- A minimum of 4 years working in an MDD/MDR /FDA Regulatory/ISO13485 environment
- Good understanding of EU MDD/MDR,FDA, ISO 13485 requirements and ability to communicate and provide training on these technical and regulatory documents
- Any experience of FDA submissions would be highly beneficial
Job Offer
Competitive Basic , Health care , Bonus
