Regulatory Affairs Assistant

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My Client a Global Medical Devices Organisation has opened a new vacancy within their Regulatory team and is looking to recruit a Regulatory Affairs Specialist - on an initial 12 Month rolling contract to be based at their offices in Leeds

The Role:

To support medical device product registration activities and product registration submissions throughout the world, in order that registrations are achieved in a timely manner in accordance with regulatory and company requirements Key Responsibilities:Support CE marking activities by compiling and maintaining appropriate Summary of Technical Documentation (STeDs) dossiers. Work independently to prepare and manage renewal applications for CE Class III devices With minimal supervision, collate information on regulatory impact of change projects and prepare regulatory submissions for re-registration activities. With supervision, prepare and manage responses to questions from regulatory bodies.Work independently to support registration activities and regulatory submissions in international markets Liaise with external partners and cross-functional project teams to obtain information and documents for regulatory submissions Manage multiple priorities and use various information sources to obtain and cross-check large volumes of information with a high degree of accuracy. Maintain information on worldwide regulatory requirements and the status of product registrations. Skills/Experience Required:EducationUniversity level (Life Sciences background is preferred) KnowledgeA good first degree in a relevant scientific discipline, or equivalent experience. Relevant experience in a highly regulated industry (e.g. medical devices or pharmaceuticals) Regulatory experience covering medical devices preferred Computer competency in Microsoft office software, data collection and general analysis tools. If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.