Regulatory Affairs Executive - Medical Devices

Atom Recruitment Ltd
From £35,000 to £40,000 per annum plus benefits
29 Sep 2016
19 Oct 2016
Contract Type
Our Client is a dynamic company specialising in manufacturing and distributing unique, innovative products within the healthcare industry. It exports its products to over 40 countries worldwide. They are now seeking a Regulatory Affairs Executive – Medical Devices . This position will be based in Watford, Hertfordshire and is a full-time permanent role. Key Responsibilities Creation and management of Technical Files for Class I, IIA and IIB Medical Devices (including but not limited to): · Efficacy data · Stability data · Design history and design development · Manufacturing instructions and procedures · Risk Management · Clinical evaluation · ER checklist Assistance for other RA Executives · Technical file data for BPR dossiers (Biocidal Procut Regulations) · Technical file data for Cosmetics Regulations, i.e. PIFs Management of ISO 13485 & ISO 9001 Quality Management System (including but not limited to): · Development of new procedures as required · Internal audits · Second party supplier audits (overseas travel occasionally required) · Post market surveillance · Control of documents and changes · Handling of complaints (customer and supplier) · Management of approved suppliers file · Packaging and artwork version control · Traceability and batch numbers · Design history of all new products · Adverse event reporting · Liaison with China office on ‘joint procedure projects’ · Document control (standards, directives, regulations etc.) · Quality Management Representation Qualifications and Experience · BSc (or equivalent) in Science · Solid experience in Regulatory affairs · Experience of the MDD 93/42/EEC with experience of Technical file building and submissions under this Directive (Essential) · Experience in Cosmetic / Personal Care regulatory affairs and / or the Biocides Directive is desirable · Ability to understand and enable implementation of regulatory standards · Experience within the healthcare industry, GDP/GMP, good documentation practices and quality systems · QA experience in running an ISO 13485 quality system is desirable · ISO trained auditor is desirable · There may be some travel required, primarily within the E.U · A strong communicator with good negotiation and relationship-building skills · Flexible, driven and self-motivated · Highly organised with good planning/prioritisation skills · A good team player In return, our Client is offering a competitive package including a basic salary of £35,000 - £40,000 per annum (negotiable dependent on experience) plus benefits. To apply for the above position, please send your C.V and a covering letter to Lorraine Roger, Director at Atom Recruitment Ltd. This job was originally posted as