Regulatory Affairs Associate

Support regulatory activities involving IVD medical devices, and food and industrial tests!

Your new company
My 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 assists manufacturers 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 and other 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 you'll 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 now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact Sandy Vo on for a confidential discussion on your career.