Medical Device Compliance Expert

A leading global pharmaceutical and medical device manufacturing organisation is looking for a Medical Device Compliance Expert to work on a worldwide product transfer program.

There are a number of medical devices being transferred from Technical Development to production sites and CMO's across the world. The Medical Device Compliance Expert will be an integral part of the global technical transfer team, ensuring that all production processes remain compliant with the relevant guidelines.

Role and Responsibilities:
Ensure that medical device production processes remain GMP compliant prior to, during and after transfers from Technical Development to commercial production
Create and maintain product specific Quality Risk Analysis (QRAs)
Create and maintain Post Market Surveillance documentation & global quality standards
Support the generation of the validation and CAPA management strategy for individual manufacturing sites to use
Support ISO 13845 certification and compliance of devices being transferred

Role and Responsibilities:
Degree educated in relevant scientific or engineering discipline, or equivalent experience
Proven experience in a GMP compliance role for medical device production
In depth knowledge of ISO 13485 guidelines

This is an opportunity to make a long term impact in the compliance processes of a multinational company. Apply now for more information.