Job DescriptionRegulatory Affairs Specialist
12 Month Contract
Partly Flexible / Remote Working
A fantastic contract role has arisen for a Regulatory Affairs Specialist to support a Medical Device Manufacturer. This will enable you to work on key projects over the next 12 months and apply your skills and knowledge to support MDR transition.
- Lead transition from MDD to MDR
- Work with new product development teams to help support regulatory strategy in bringing through and registering products
- Work on regulatory submissions, technical files and other documents to drive regulatory function forward
- Remediate or create technical documents as required
- Strong knowledge / experience of regulations particularly around MDD to MDR transition
- International standards and regulations knowledge including; MDR, ISO13485, ISO14971 and Medical Devices Directives.
- Global registrations experience
- Experience supporting and working alongside new product development teams