QA/RA Director

North West England
04 Apr 2013
02 May 2013
Steven Ruddy
Full Time

Regulatory Affairs Consultant MD/IVD's £50ph north west

My client in the north west is looking for a senior regulatory affairs consultant for the regulatory guidance on cross functional new product development project teams in the design and development of innovative blood glucose products. This role also involves working with external agencies to progress product submissions to approval as well as obtaining advice on product Classifications and submission requirements.

Regulatory Project Manager

* Develops, defines and executes the regulatory project plan including applicable regulatory submission schedule deliverables.

* Responsible for the preparation of Global Regulatory Strategies to support the registration of new and modified products.

* Prepares and submits 510(k) submissions and CE Mark Technical files. Also completes

* Global registrations in concert with regional affiliates for initial launch plan.

* Interfaces with Regulatory Authorities and Notified Bodies to address RA questions and submission issues.

* Manages development and implementation of department projects to improve the overall effectiveness and efficiency of the department activities as a team leader and individual.

You MUST have experience with the above and extensive regulatory affairs experience within medical device companies.

Regulatory Affairs Consultant MD/IVD's £50ph north west

Please contact Steven Ruddy from Real Pharma - Medical Devices on 0207 758 7322

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