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2x Senior Reg Affairs Executive

Job Title: 2x Senior Reg Affairs Executive
Contract Type: Permanent
Location: Glasgow, Scotland
Industry:
Salary: £28000 - £34000 per annum
Start Date: 2018-02-15
Reference: 77799
Contact Name: Paul Rees
Contact Email: Paul.rees@nesgt.com
Job Published: February 15, 2018 17:32

Job Description

Senior Regulatory Affairs Executive - £34,000 – Glasgow

I am currently recruiting 2x Senior Regulatory Affairs Executives to join a global medical device company based near Glasgow.


Key Responsibilities
  • Preparation of regulatory documentation and submissions for product approvals.
  • Development of regulatory plans/strategies for new products and changes to existing products
  • Participation in Design Control, Risk Management and Post Market Surveillance activities
  • Production and review of design dossiers, technical files and change assessments
  • Review and preparation of regulatory paperwork in accordance with International standards and new regulations
  • Review of product packaging, labelling, IFUs and marketing literature for compliance with specific country regulations
  • Facilitate compliance with Vigilance System.
  • Provide regulatory input to functional groups as required
  • Participate in review of RA procedures
  • Other duties as required by RA department..
 

The Successful Candidate
  • Will be degree qualified in a technical life science related discipline. (Biochemistry, Chemistry, Biomedical, microbiology or related discipline).
  • You will also have experience in Quality Assurance or Regulatory affairs ideally from a medical device background.
This is part of a major expansion project following significant investment into the organisation (£30m), they work with lifesaving class III Medical devices which are sold in over 180 countries.


These positions are immediately available and offer fantastic career progression prospects.


Please apply online or for more information, please call Paul on 0161 942 4035