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Derby, Derbyshire
Quality and Regulatory Affairs Manager
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Job Type: Full-time |
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Salary: £40,000 per annum |
Overview
We are recruiting exclusively for Medartis - an International company in Medical Device Industry - a Quality Management Representative with knowledge of Regulatory affairs. The salary is negotiable and depends on experience. Job requirements: 5 years of working experience in QMS Medtech 2 years of working experience in Regulatory Affairs MedTech Being able to implement the QMS system at Medartis UK Tasks and responsibilities: elaborating all the business processes relevant for an ISO 13485 certification with the UK team verifying that product meets specific requirements (e.g. CE-mark; DoC; accompanied information; UDI etc.) ensure that storage or transport conditions comply with the conditions set by the manufacturer inform the manufacturer about any non-conformities of the product in the market, in cases of serious risks caused by the device informing the national competent authorities. Supporting any corrective action taken to bring the device into conformity Forwarding complaints or reports received from healthcare professionals to the manufacturer Keeping a register of complaints, non-conformities, recalls and withdrawals and keep the manufacturer informed of such monitoring and provide information on request Contact point to competent authority, providing all the information and documentation that is at their disposal and able to demonstrate conformity of the product Ability to identify the full supply chain to the competent authority (to whom they supply; who has supplied, any health institution or healthcare professional to which have supplied) Storing and keeping the UDI of the devices in certain cases Registration as a distributor based on national provisions Ensuring that all appropriate corrective action is taken of all devices available on the market without delay. Responsible for the QMS systems in the UK Contact point for Quality/Regulatory processes in outsourced loan service