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Job Description

We are currently working on a Quality and Regulatory associate for a leading Medical device organisation that can boast to be a market leader within its field.

Working closely with the QA/RA Director your role will be to support the UK & Ireland business with all their post market activities including but not limited to;

  • Development and implementation of RA/QA processes and procedures as directed to support EU post-market surveillance and Authorised Representative
  • Maintenance of any databases used to support UK post-market surveillance and authorised representative
  • Submission of registered details of the Authorised Representative with relevant Competent Authorities
  • Support Director QA & RA, as directed on matters associated with Company’s Quality Management Systems and Authorised Representative processes.
  • Identification and maintenance of documentation required to allow the Authorised Representative to fulfil the role and responsibilities required

Additional responsibilities include:

  • Providing metrics, reports and assistance to the Director of QA/RA as required.

  • Liaise with internal and external customers and Regulatory Agencies as required to ensure good partnerships are established.

  • Provide training as required to ensure the company remains in compliance with established European quality system requirements, particularly in relation to post market surveillance and the EC authorised representative.

 

To be considered for this position candidate ideally will need to have at least 2 years’ experience working within a medical device business in a QA/RA role, however our client will also consider individuals who have a Biomedical Engineering Degree (or Similar) who has a years experience in a commercial role looking to enter into this field of work. However in this case candidates will need to be able to demonstrate an understanding of the Quality and Regulatory function.

This role will play a pivotal role for our client in the UK, therefore you will need to possess excellent communication skills and an eye for detail.

 
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