Certification Decision Maker

29 Nov 2018
13 Dec 2018
Quality, QA / QC
Contract Type
Certification Decision Maker

Job type: Permanent

Location: Home Based

A leading global Medical Device Notified Body is currently seeking to hire a Certification Decision Maker to join their growing team in Europe. You will play a key role in the company’s growth strategy and success of their business. Additionally, you will be able to make an immediate impact on their European operations as the business continues to prepare for the MDR.

Key responsibilities of the Certification Decision Maker include:

To perform Technical Documentation Independent Review Process

To Perform Technical Documentation Certification Authority Decisions. Including suspensions, transfers, reinstatements and withdrawals.

To Perform Audit Report Technical Review and Certification Decisions, (auditor qualification dependant).

Provide assistance, participating in disputes and appeals Investigations received from clients and make decisions on whether upheld or not

To Attend Panel Meetings, to review certification decisions proposals, providing decisions.

Key requirements of the Certification Decision Maker include:

3+ years’ experience in Quality Assurance and Management on a global or multi-site scale

Has preferably at least 3 years’ experience of either working in a Health Science related industry in Clinical Affairs, Design, Manufacturing or Quality and Regulatory functions, or previous experience with either Management System registrars, Notified Bodies or Testing laboratories

Have a good knowledge the EU Medical Device Directives and Regulations and Quality Management Systems

If you are interested in the Certification Decision Maker position, apply online today or contact Jamie Remp at +44 203 758 8975 for more information

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