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QARA Manager

2 months ago

Northamptonshire UK, East Midlands, United Kingdom GxPeople Global Full time

GXpeople are supporting a Medtech company who are looking for a QARA Manager to oversee their QMS to ensure compliance with the applicable requirements of the essential requirements of the MDD 93/42/EEC and MDR (EU).


This candidate will be responsible for ensuring the ongoing compliance of the ranges of Class I medical devices, with particular focus on Clinical Evaluation Files, Post-Market Surveillance and Risk Management.


Main Responsibilities


• Managing a hands-on plan of action to audit and improve Technical Files,

• Documentation and implementation relating to technical file management

• Ensuring compliance of devices to all applicable regulations.

• Drafting, maintenance and review of EC declarations of conformity

• Maintain registration of devices on applicable online databases

• Evaluating regulatory requirements for new markets and existing international distribution agreements


Qualifications & Experience

The following requirements should be supported by strong qualifications or relevant working experience:


• Experience of working within the medical device industry is essential and knowledge of the EU MDR, UK MDR & US FDA 21 CFR 820 is essential

• Strong understanding of ISO 13485

• Experience drafting Clinical Evaluation Files in compliance


Please apply to this advert for more information.


Please not you must have perpetual right to work in the UK and this is a 100% on site position.