Would you like to be involved in developing cutting edge technology improving the lives of patients around the globe? I’m currently working with a MedTech SME in Oxford city centre who are seeking an experienced RAQA Manager who will be responsible for global regulatory affairs and corporate quality assurance activities.
Quality & Regulatory Manager, £50-60k, Oxford, Medical Devices
• Preparation for transition to EU MDR including the up-rating of device classifications and also for transition to MDSAP
• Oversight of Post-market surveillance and CER process for all products.
• Liaising with regulatory authorities, distributors, Notified Bodies and partner companies.
• Writing and submitting 510(k) pre-market notifications to FDA.
• Technical file compilation and maintenance, company registration and regulatory submissions worldwide.
• Quality System auditing. Process design and implementation.
• A minimum of 4+ years of experience in regulatory affairs or in quality management systems relating to medical devices
• Experience preparing FDA submissions, license applications, registrations and other product approval documentation and demonstrated knowledge of applicable requirements and practices
• Broad knowledge of medical device regulations (e.g. ISO 13485, etc.)
• Project Management experience
Please contact Nathan Berkley on 0203 019 6020 or email email@example.com if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.
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Find out more about us at www.peoplewithchemistry.com and https://www.linkedin.com/in/nathan-berkley-a25811139/