RA/QA Manager

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Job description

Exciting new Regulatory Affairs opportunity, at a rapidly growing Pharmaceutical companies!

They are looking for a Regulatory Affairs professional with experience in Quality Assurance, and auditing of Medical Device, to join their team in a Manager role.

The key responsibilities of this role include:

* Perform *QMS/regulatory audits* of clients to European Directives and Regulations

* Preparation of *audit plans* covering internal and external audits of company suppliers and other business partners

* Liaison as required with regulatory or certification organisations or agencies to resolve any issues arising from audits or related activities

* Knowledge of *GMP, GDP* and *MDSAP* QMS compliance requirements desirable

We're looking to speak with any candidates that have:

* *5+ years' experience* working in the Medical Device industry

* Experience with *imports, and exports* of Medical Device

* Extensive of *Medical Device Regulations (MDR)*

* Experience with *QA documentation Development*, and *QMS*

This is a permanent Regulatory Affairs opportunity which is offering an extremely competitive package and, looking for someone to be able to travel to the Basingstoke office 2-3 times per week.

If this sounds like the ideal role for you, please send your CV to [](mailto:). If this does not sound like the right role for you but you know someone that could be right, please forward on a method of contact to this person and you could be eligible of a referral fee. Also, we have a variety of roles that could be of interest but might not be advertised due to NDAs so please do feel free to send over your profile and we will be in touch with relevant positions.

Regulatory Affairs

Medical Device audits

Medical Device Regulations (MDR)

Quality Assurance

QMS

Permanent

Pharmaceutical