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Quality Assurance Regulatory Affairs Associate
Bishops Stortford, Essex �25,000 - �30,000 PA Pro Rata TP544 permanent position	My client is looking for a Quality Assurance/Regulatory Affairs Associate to join their team on an initial 6 month contract with a view to a permanent contract. You will need to be an excellent communicator with the ability to work with a variety of people at all levels. You should be a confident and assertive people with the ability to work successfully as part of a team. As well as proficient IT skills, the successful Quality Assurance/Regulatory Affairs Associate with need to have specific knowledge of: � ISO 60601-1 � ISO 60601-1-2 � ISO 9001 � ISO 13485 � Medical Device Directive 93/42/EEC � USA FDA 21 CFR Part 803 � Quality Management Systems Desired Experience: � Preparing and administrating an FDA 510k submission � Constructed and coordinated risk assessments to ISO14971 � Prepared and created CE Technical Files � Preparation and support of regulatory submissions � Internal and external auditing � Experience of carrying out clinical literature reviews for medical devices The Quality Assurance/Regulatory Affairs Associate rewards: � Initial 6 month contract � �25,000 - �30,000 PA (pro rata)

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