The role: To provide regulatory expertise in the research, development and marketing of Advanced Wound Management products and to ensure that regulatory approvals are obtained...
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.
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 registrations
Management of the organisations internal audit programme.
Coordinate and control external consultants required to deliver key aspects to the technical files (BER/CER etc)
Life Science Degree Qualified
Extensive experience in a regulatory capacity within the medical device industry
Sound 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 revisions
Compliance 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 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.