Regulatory Technician Opportunity for a World Leader in Orthopaedic Innovation

Flame Pharma are currently working very closely with a highly successful, rapidly expanding company in Gloucestershire to recruit a Regulatory Technician to join their talented and dedicated teams in a safe and stimulating working environment. Reporting to the Regulatory Affairs Manager,you will be responsible for technical and regulatory support in the areas of sterilisation, cleaning and packaging and various validations surrounding these processes. In addition, you will be responsible for the routine monitoring of the cleanroom and regulatory issues surrounding it in line with ISO 13485, MDD and QSR and the provision of sterility assurance in line with ISO 11137 and ISO 11135. In order to be considered, candidates must be educated to degree level in an engineering/life science discipline or equivalent and have a sound knowledge of ISO standards, the medical Device Directive 93/42/EEC (as amended), and other regulations, legislation and standards applicable to medical devices.

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