Regulatory Affairs Officer

SRG Clinical
05 Oct 2017
02 Nov 2017
Contract Type
Full Time
The role: Using acquired industry knowledge within Regulatory Affairs to enable products to meet applicable regulations and standards.Displaying ability to analyse changing regulations and guidance to identify any data needed to ensure certification on current products and for the development and launch of new products. Key Responsibilities:Compile and prepare technical dossiers for submission and assessment by Regulatory bodies.Life cycle management of existing technical dossiers/products.Developing regulatory strategies to ensure effective registration of products.Lead re-certification processes for current products (CE marks)International product registrationsManagement of the organisations internal audit programme.Coordinate and control external consultants required to deliver key aspects to the technical files (BER/CER etc) Skills/Experience Required:Life Science Degree QualifiedExtensive experience in a regulatory capacity within the medical device industrySound knowledge of International (harmonised) standards in particular: ISO 13485, ISO 14971 and related standards, Medical Device Directive 93/42/EEC, Canadian Medical Device Regulations SOR/98-282 and revisionsCompliance experience with (MDD class II and higher)Experience working in New Product Development projects 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 589626The 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.