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Job Details

Regulatory Affairs Specialist - Oxfordshire, UK

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

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,



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.


  • 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 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
Tel:  0044 1707 830300
Website:  Visit Our Web Site

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