Senior Compliance Engineer

Astor Bannermans Medical Device product line is continually evolving and growing. We require an experienced compliance engineer to help us navigate our regulatory requirements for new and existing products. If you want to be part of a company creating products that directly improve peoples lives, then this is a perfect opportunity. Requirements Youll be a technically capable and detail orientated engineer with experience in medical device testing and certification, with a strong grasp of compliance standards. A relevant degree i.e. Engineering (Elec eng. preferred), Medicine or another relevant scientific discipline or 6+ years experience in a compliance or regulatory affairs role. Hands on experience in product testing and validation Knowledge of regulatory requirements for Class I medical devices to MDD and MDR. Experience and competence complying to ISO9001, ISO13485, ISO14971. Experience testing and complying to IEC60601-1 and other parts (such as -2, -6, -11) Strong analytical and...

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