A fantastic opportunity for a senior QA/RA Manager has come about to work with a fast-expanding Medical Device company in the m4 corridor. This company have developed innovative and cutting-edge technologies and require a QA/RA manager to join their growing team as they look to strengthen their QA/RA function.
• Managing the UK Quality Assurance and Regulatory Affairs team.
• Maintain the Quality Management systems at the and facilities to meet the requirements of ISO 9001, ISO 13485 and the IVD Directive (98/79/EC) and the company’s Quality Policy
• Communicating and maintain compliance in adherence to ISO 13485 IVDR and 21 CFR 820.
• Overseeing the Quality Site Objectives
• Management of CE marking
• Hosting Regulatory Agency Audits (FDA, Notified Body, etc)
• Assisting with the quality team activities
• 5 years experience in a QA/RA Manager position in a Medical Device/IVD company
• Knowledge of CE Mark Technical Documentation and IVD CTS documentation requirements
• QA/RA team management
• A strong background working with IVD Devices
• Knowledge and experience with, ISO 13485, 21 CFR 820
• Experience of full project life cycles
Full job description and company details are available upon application, apply below. This position is being dealt with by Joseph Dykes at Meet, please call 0203 178 7488. You can also e-mail us directly at Joseph@peoplewithchemistry.com to discuss in confidence.
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