Regulatory Affairs Specialist

SRG Clinical
01 Oct 2017
03 Nov 2017
Contract Type
Full Time
Key responsibilities: * Offer general advice on regulatory strategy for new products and product changes. * Working on 510k submission on a day to day basis with minimal supervision. * Provide updates on the progress of registration processes and other RA group activities to line management when requested. * Assistance with the regulatory compliance of marketing communications/messages. * Contribute to the development and implementation of regulatory policies, procedures and specifications across the company and ensuring that these are compliant with the Quality System. * Undertake CE marking activities and has a good understanding of the requirements of the IVD directive. Ability to recognize post market surveillance issues that require corrective action and reporting. Education:Life sciences qualified. Experience: * A scientific, medical or engineering background. * Significant regulatory experience. * Knowledge of the IVD industry or the medical devices industry. * Knowledge of GMPs/ISO13485, FDA 21 CFR 820 - 510k process, IVDD - CE marking and ROW regulations/registration processes. * Understanding of pre/post marketing regulatory affairs. 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 589673The 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.