Regulatory Affairs Specialist

Regulatory Affairs SpecialistSalary: £30,000 - £35,000 DOE plus benefitsLocation: BedfordFull-Time; 12-month Fixed Term ContractThe VacancyOur client is a world leader in the research, design and supply of advanced consumer diagnostic products. They have a joint venture, and their brand is recognised the world over as providing accurate home pregnancy and fertility monitoring tests.They are looking for a Regulatory Affairs Specialist to join their Regulatory Affairs team on a full-time, 12-month fixed term contract.The role will be based at their Innovation Centre in Bedford, UK with option for hybrid working.The Regulatory Affairs Specialist role provides technical support for the Regulatory Affairs Department, ensuring regulatory elements of international distribution of our client''s products, and implementation of changes to products in production are fulfilled.This role supports validation of product claims on a market specific basis and makes sure up to date documentation is available for all marketed products. The role holder will perform regulatory reviews of complaints for reportability, and report as necessary.Our client is looking for someone who holds a minimum of BSc Degree or equivalent experience in life sciences (e.g. biological sciences, biochemistry, pharmacology etc.) and has comprehensive working knowledge of CE marking requirements for in vitro diagnostic medical devices or medical devices, and knowledge of international regulations for medical devices. ..... full job details .....