Job DescriptionRegulatory Affairs Manager
12 Month Contract
£65-75 per hour
Home / Flexible Working
NES are currently partnering with a large Medical Device business going through large scale remediation projects across their product lines for MDR as well as looking to complete on multiple product registrations and submissions in the US & APAC regions.
To manage the business's regulatory affairs strategy relating to MDR transition and the associated remediation work involved. You will be required to communicate at all levels within the business and with external partners.
The business is also looking to register products in the US & APAC regions so previous experience to support on these projects will be beneficial, particularly with class 2 & 3 devices.
- Create, manage, and maintain Tech Files
- Overseeing CE Marking
- Leading the transition from MDD to MDR for the business
- Complete product registrations and submissions in US and APAC regions
- Lead the development of the company’s regulatory plan, incorporating strategies for the product range in accordance with global requirements.
- Support product risk management activities
- Knowledge & experience of ISO 13485 and MDR requirements
- Demonstrate strong project management skills.
- Excellent communication skills
- Working with class 2 & 3 devices would be an advantage