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Job Details

Regulatory Affairs Specialist - Oxfordshire, UK

Company: Just Pharma
Location:
Reference: SWRASIVD0217
Closing Date: 27 Feb 17
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

Just Pharma are currently working with a Medical Device and IVD company who are now searching for a Regulatory Affairs Specialist to join their growing team in the Oxfordshire area,

Requirements:

Overview

This position will be responsible for ensuring the continued compliance of the organisation’s products and processes with the requirements of IVD Directive 98/79/EC and the Medical Device Directive 93/42/EEC and othe applicable regualtions.

Responsibilities

  • Perform review of Technical Files for CE marked products and maintain in compliance with European guidelines.
  • Implement process to ensure compliant maintenance of international regulatory submissions 
  • Provide regulatory support to new product development and change control processes.
  • Ensuring the compliance of risk management files to ISO 14971:2012.
  • Regulatory review of product labelling and promotional materials.
  • Implement and develop internal regulatory procedures·        
  • Keep abreast of developments in legislation and other applicable statutory changes which may affect the product portfolio.

Required Experience

  • Bachelor of Science Degree or equivalent qualification
  • Experience of working as part of a team and of working to clear deadlines
  • A working knowledge of the EMEA In-Vitro Diagnostic/Medical Device regulatory affairs environment including but not exclusive to: Regulations, Submissions, Technical Files.

If you would be interested in discussing this position in further detail please feel free to contact me, Simon on simon@justpharma.co.uk or call 0044 (0)1707 817629.

 

Regultory Affaris Specialist, Regulatory Affairs, RA Specialist, Regulatory Affairs Associate, RA Associate, Regulatory Submissions, Medical Device, In Vitro Diagnostics, IVD, IVD 98/79/EC, MDD 93/42/EEC, ISO 13485, ISO 9001. Oxfordshire, UK, United Kingdom

Apply for this job: Regulatory Affairs Specialist - Oxfordshire, UK

Contact Information:

Address:  Head Office
2nd Floor Albany Chambers, Bridge Road East, Welwyn Garden City, Hertfordshire
AL7 1HL
England
Tel:  0044 1707 830300
Website:  Visit Our Web Site

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