The Role
This is an exciting opportunity for someone develop their career in Regulatory Affairs in a market leading, medical devices company. You’ll be responsible for ensuring their supply chain operations comply with all relevant quality legislation.
1. Creating, updating, and reviewing technical files for ClassI-IIb Medical Devices
2. Post market surveillance
3. Responding to regulatory enquiries, internally and externally
4. Assisting the RA Manager and RA/QA Consultant with regulatory related tasks
You
To apply for this role as Regulatory Affairs Senior Associate our client is hoping for someone with the following skills and experience;
5. Ample experience in Regulatory Affairs specifically within medical devices (2-5 years’ experience ideally)
6. Full lifecycle RA experience ideally, however just pre or post approval will also be considered
7. Knowledge of ISO 13485, MDD, MDR
8. Excellent attention to detail
9. Within a commutable distance to West Yorkshire as this role will initially be onsite, with the potential to be hybrid after probation has been passed