Regulatory Affairs Manager - RA/QA

Must have Medical Device Regulatory Experience London Based About Our Client My client is an established medical device business with a small team based in London. They currently have a device approval in Europe and are expanding to other regions including the USA. They are looking for a Regulatory Affairs Manager - RA/QA to join the high-performing team. Job 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 The Successful Applicant University degree in a 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 What's on Offer Competitive Basic, Health care, Bonus

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