Regulatory Affairs Manager, Oxford, Medical Devices, £DOE

Job Reference: #30009 Add to saved jobs

  • Location Oxford, Chipping Norton, Banbury, Newbury, Swindon, Witney, Gloucester, Cirencester, Reading, Aylesbury, High Wycombe
  • Permanent
  • Sector Medical Devices

Job Summary

Are you looking for your next exciting challenge working for an international organisation? I am working on a fantastic opportunity in the Oxford area enabling you to become an integral part of the team and excel your career. This start-up medical device company are using world leading research to implement great changes within the industry resulting in improved patient outcomes.

Job Overview

• Preparing Regulatory strategy for pre-market applications and related submissions
• Providing guidance to cross functional product development teams regarding conformance with medical device regulations and standards
• Developing international product registrations
• Developing regulatory labelling
• Reviewing and evaluating EU regulatory impact of proposed product changes
• Providing guidance and supporting other regulatory and quality staff and project team members

Skills Required

• 5+ years medical device or IVD experience
• Knowledge & understanding of EU and medical device regulations
• Demonstrated success in preparing medical device pre-marketing applications and CE mark technical files

• Quality management experience
• Knowledge of FDA medical device regulations and 510k processes
• Technical experience gained in an R&D lab setting

Contact Details

Please contact Nathan Berkley on 0203 019 6020 or email if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

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