Quality & Regulatory Affairs Professional - Scotland

Very attractive staff salary - Regulatory and Quality - Medical Devices
Ref: 971 Date Posted: Tuesday 10 Apr 2018
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Entrust People have a fantastic opportunity for a Quality & Regulatory Affairs professional to join our client, a leading and industry leading life Science business. The role is offered on a full time permanent basis and will report into the Chief Technical Officer. This role will take a technical lead in quality and regulatory affairs related to biologics.

Key aspects of this role are:

·         Working with the QA and regulatory affairs manager (devices) to maintain and improve the current Quality Management System ensuring suitability for US FDA licenced combination product (device / biologic)

·         Assist in the preparation of regulatory submissions for US FDA and rest of world

·         Auditing of biologics supply chain manufacturers

·         To provide guidance and leadership for all matters related to quality and regulatory affairs associated with biologics

·         Responsible for regulatory compliance

·         Preparation and review of quality documentation, reports and SOPs

 

We are looking for:

·         Degree qualified, ideally within Life Sciences or Quality Management  

·         Experience of development, preparation, submission and maintenance of FDA PMA submissions & EU Technical Files etc.

·         Experience of managing and maintaining quality management systems

·         Auditing experience to US FDA biologics 21CFR600 standards

 

In Return

·         Very attractive staff salary

·         Industry Leading Project

·         Fantastic Team Collaboration

·         Great Working Environment

 

Please contact me on 01224907990 or send your details/enquiries to paul@entrustpeople.co.uk for further information.