Regulatory Affairs Associate

Job Description

Support regulatory activities involving IVD medical devices, and food and industrial tests! Your new companyMy client has over 20 years experience in developing, manufacturing, and distributing high quality IVD medical device products for clinical and food laboratories. Their clinical range supports healthcare providers whilst their food diagnostic range assistsmanufacturers in ensuring consumer safety. This Regulatory Affairs Associate role will be based in their Camberley site, communicating with internal teams on activities such as document creation and review, and remediation of technical files towards IVDR andother application regulations. Your new role

• Working on IVD device files, including intended use statements, risk management files, manufacturing and labelling processes, product verification and validation, performance evaluation, and post market surveillance;
• Supporting product registrations globally;
• Working with internal teams to achieve consistent regulatory compliance for all devices;
• Working on the Brexit plan for CE marking, UKCA marking, and suppliers.

What youll need to succeed

• Tertiary qualifications in science or equivalent working experience;
• Knowledge and experience of working to appropriate standards including IVD Directive 98/79/EC and IVD Regulation 2017/746, ISO 13485, ISO 14971 (FDA 21CFR part 820 desirable);
• Knowledge of technical documentation towards regulatory submissions or product registrations;
• Experience of working with cross-functional teams preferably in an IVD or medical device environment.

What you need to do nowIf youre interested in this role, click apply now to forward an up-to-date copy of your CV, or call us now.If this job isnt quite right for you but you are looking for a new position, please contact Sandy Vo on for a confidential discussion on your career.