Medical Devices - Regulatory Affairs

My client is a global supplier of medical technology for critical care, operating theatre and home healthcare applications.They are seeking someone with experience in Regulatory Affairs within Medical Devices to join their growing team at the Sussex HQ.

Below is a brief description.

Purpose of 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.

Reports to – Head of Quality Assurance and Regulatory Affairs

Accountabilities

•  Prepare submissions / compliance strategy documents in line with agreed timeframes.
• Support Generation and completion of technical documentation in line with agreed timeframes
• Hands on in the remediation of technical files with agreed timeframes

If you believe this roll is the next step in your career, please contact Christian. Christian is a Regulatory Affairs specialist who is keen to help individuals find there next step in there pharmaceutical career.

Please contact Christian on 01293 776 644, alternatively email at christianlee@barringtonjames.com.