Global Medical Devices Auditor
A hugely exciting opportunity to work with a global leader in the rehabilitation sector.
This client of ours are hugely established in their market, designing, developing and distributing products on a global scale - with a great reliable reputation int he industry.
They have an opportunity available for a Global Medical Devices Auditor to work from the UK office, but travel globally when necessary.
General responsibilities will include proficiency at assignments such as establishment registration & listing, international product registrations, export certificate submissions, new product development support as well as the ownership of medium sized Regulatory Affairs projects.
The ideal candidate will have the following qualities/experience:
-Knowledge and understanding of US FDA, Canada, Australia, Brazil, Japan & ISO 13485:2016 regulation.
-Use Quality Management System through MDSAP
-Must understand the grading system of MDSAP and be able to carry out the MDSAP audit for each site
-Must be able to conduct a gap analysis to identify the gaps
-Must be able to update/revise/create procedures based on ISO 13485:2016 requirements
-Must be lead auditor certified by an accredited company
-Must have an excellent communication skills and be able to work with different departments throughout the company.
If interested in discussing further, please get in touch ASAP.
This job was originally posted as www.totaljobs.com/job/81450942