RA Associate - new job in Blackwood, UK

Here at SRG, we are pleased to be partnering with this global diagnostics company that has been operating for over 50 years. They are currently looking for a Regulatory Affairs Associate to join their team based in South Wales.

As the Regulatory Affairs Associate will assist the Regulatory and Product Stewardship Leader with the technical aspects of Regulatory Affairs including but not limited to compilation, submission and maintenance of the registrations and technical documentation in accordance with the country specific requirements to relevant Regulatory Authorities.

Responsibilities and Duties including but are not limited to the following:

• To maintain the relevant Global, local Regulatory and compliance databases
• Be responsible for maintenance and preparation of technical documentation, including labelling and information to be provided, as well as preparation of registration documents for IVDR, FDA, CE, UKCA
• Prepare and submit regulatory submissions to global regulatory authorities as required for global approvals for in vitro diagnostic (IVD) products (FDA, CE, UKCA) as a legal manufacturer and also for PLM customer, including preparation of documents (such as Technical Files and artworks) and interaction with regulatory officials as required.
• 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.
• Ensure that all company's products comply with the regulations of the regions where sold.
• Keep up to date with national and international legislation, guidelines, and customer practices.
• Literature research on legal requirements for territory registrations and regulatory affairs updates
• Conduct Post Market Surveillance activities by collecting, collating and evaluating scientific data from a range of sources.
• Actively participate in global external audits in relation to ISO, MDSAP, FDA, IVDR, notified bodies and/or regulatory inspections.

As the ideal candidate, you will have a BSc or equivalent in Bioscience, Chemistry, Quality Management or related Science qualification. You will have 3-5 years' experience working within regulatory affairs for the IVD/Medical Device industry. You will have knowledge of QMS ISO13485, 21 CFR Part 820 as well as IVDD, IVDR (preferably).

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.