This vacancy is now closed

Director of Quality and Regulatory Affairs - Edinburgh

Regulatory and Quality - Regulatory Affairs & Quality
Ref: 1008 Date Posted: Tuesday 08 May 2018
Share
More

Entrust People have a fantastic opportunity for a Director of Quality & Regulatory Affairs 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:

  • To oversee, maintain and improve the current Quality Management System maintaining CE mark for company’s products within EU territories, ISO13485 accreditation and FDA PMA in US for combination product (device / biologic)
  • Preparation of regulatory submissions for EU, US FDA and rest of world for the organisations imaging system combination product and other products as they become available
  • To provide guidance and leadership for all matters related to quality and regulatory affairs.
  • To support applications, amendments and supplements, and variations for device / product licences within EU, US, Canada and other territories.
  • Auditing of suppliers and potential suppliers (ISO13485, 21CFR820, ICH Q7, 21CFR211)
  • Preparation and review of quality documentation, reports and SOPs in a professional and timely manner
  • Identify and take responsibility for achieving personnel training standards required in quality and regulatory affairs
  • To provide a technical lead in quality and regulatory affairs

We are looking for:

  • Degree qualified, ideally within Life Sciences or Quality Management  
  • At least 5 years of experience within GxP setting
  •  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 Retur

  • Very attractive staff salary
  • Industry Leading Project
  • Fantastic Team Collaboration
  • Great Working Environment

 

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