SRG are working with an exciting biotechnology organisation with a global presence to help them find a Department Lead within Regulatory Affairs (RA). This is a great opportunity for someone with a wealth of experience in the field of Regulatory Affairs within IVD/IVDRs. The company offer an excellent benefits package and a chance to lead an experienced team. The role: Serve as a member of the Regulatory and Quality Management Team for oversight and guidance of the entire organisation on RA and Quality strategy and activities Manage, prepare and maintain regulatory documentation to enable the Company to comply with ISO13485 standard and to ensure regulatory compliance with the 98/79/EC IVD Directive (IVDD), Regulation (EU) 2017/746 (IVDR), FDA Code of Federal Regulations and Canadian Medical Device Regulations, Part 1 as well as regulations required for rest of world submissions. Interpret complex legislation and provide expert advice on all aspects of US FDA, European and worldwide Regulatory Legislation and collaborative undertakings with external organisations. Assist with the implementation of the Company's Quality Policy to ensure compliance with Good Manufacturing Practice (cGMP), ISO13485 standard, the 98/79/EC IVD Directive, Regulation (EU) 2017/746 (IVDR), FDA Regulations, Health Canada Medical Device Regulation, Part 1 (SOR/98-282) Contribute to the design and implementation of new quality systems and procedures and ide...