Regulatory Affairs Engineer - Medical Devices

2 + years experience in Regulatory affairs?

Experience in Medical Devices/Technology?

I have recently partnered with a leading, global organisation who are a global supplier of medical technology for critical care, operating theatre and home healthcare applications, they are looking for a Regulatory Affairs Engineer to continue the teams growth in their Sussex HQ. My partners mission is to provide high quality innovative products to patients and caregivers around the world that help to improve patient outcomes and efficiencies of healthcare organisations with patient focused customer service and technical support.

The Role -  Responsible for maintaining and supporting promotion of regulatory affairs and supporting overall regulatory compliance. The position provides and contributes to the delivery of regulatory deliverables from internal R&D (research and development) projects, contributing to provide regulatory solutions to business requirements and changes to regulatory landscape. The position provides operational regulatory input and guidance to cross functional terms, ensuring compliance MDSAP (medical device single audit programme) and other applicable global regulatory standards. Furthermore, the Regulatory Affairs Engineer is responsible for the completion of global regulatory submissions for product registrations in line for business to growth.

Experience Required

- Comprehensive and demonstrable experience of working within Regulatory Affairs in a Medical Device Environment (2 years within Regulatory Affairs)

- Preferably 11a / 11b experience

- Experience of working with IEC 60606/IEC 62304 would be advantage