Your new company We are seeking an experienced Regulatory Affairs Specialist to join the Technical Documentation team on a contract basis.This is an excellent opportunity for a regulatory professional with strong IVD/IVDR expertise to play a key role in the preparation, remediation, and maintenance of technical documentation supporting a complex product portfolio. You will work within a global regulatory environment, collaborating with cross-functional stakeholders to ensure compliance with evolving regulatory requirements. Your new role Compile, review and maintain IVD/IVDR Technical Documentation in line with EU regulatory requirements. Author and update technical files and associated regulatory documentation. Support technical documentation activities related to a strategic divestment project. Review existing documentation for compliance gaps and support remediation activities. Develop and maintain regulatory content including: Technical Files / Technical Documentation Summary Technical Documentation (where applicable) Labelling and regulatory content Instructions for Use (IFUs) Collaborate with Regulatory Affairs, Quality, R
Regulatory Affairs Specialist IVD employer: Hays
Join a well-established ecological consultancy in Kent that prioritises work-life balance and professional development. With a collaborative team culture and a commitment to delivering high-quality ecological advice, this company offers meaningful career progression opportunities for ecologists. Enjoy flexible working arrangements and the chance to work on diverse projects across the South East and beyond.
