Global Medical Devices Auditor

Invenia Resourcing Ltd
16 May 2018
24 May 2018
Contract Type
Full Time

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.

Thank you.

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