Regulatory Affairs Officer

4 weeks ago


North East, United Kingdom Templarfox Full time

Regulatory Affairs officer My client, based in Yorkshire is an innovative IVD company looking to recruit a Regulatory Affairs (RA) officer to join and support the development of new and innovative products on a permanent basis based in Yorkshire. This is permanent role is for immediate start. Responsibilities for Regulatory Affairs (RA) officer Working as part of the quality team on novel IVD products from development to manufacture, with tasks including: - Updating and maintenance of databases and licences held by Abingdon Health. - Preparation, submission and tracking of documents (such as Dossiers, Product Information Files, Technical Files and artworks) for regulatory submissions. (FDA, CE, UKCA) - Conducting post market surveillance - Provide ongoing regulatory advice to project teams throughout product and process development, ensuring regulatory concerns are planned and accounted for and the relevant data generated to meet project objectives. - Coordinate projects for clients of the regulatory consultancy service. Managing the project plans to ensure delivery, including working with multiple internal stakeholders/departments - Co-ordinating, running and minuting of project meetings - Management of project document in line with organizational procedures - Communicating with customers throughout the project lifecycle - Assist in external audits (BSI, FDA, MDSAP) and/or regulatory inspections. Personal Skills for Regulatory Affairs (RA) officer - Previous 1-2 years experience in a quality assurance role within an ISO 13485 environment - Attention to detail and accurate reporting and quality purposes - Good time management and prioritisation skills - Flexible and adaptable to new techniques and skills - Organisational and planning skills - Team player The ideal candidate for this role will have a degree in a relevant scientific subject and have experience at working in a similar role within as a Quality Assurance officer within a chemical, CRO, IVD, medical device (ISO 13485) or pharmaceutical company. If you believe you hold the relevant background experience and looking for a new role as a RA officer within a successful expanding business then this is the role for you. About us: Templarfox if a privately owned recruitment business leading in executive search, management selection, Salary benchmarking and Business development services. The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK and on this occasion TemplarFox Consultancy is acting as an employment agency. Key Words: QA, Quality Risk Management, Quality Systems, Supplier Management, Audits, CAPA, Quality Assurance, QMS



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