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RA Officer

Stem Recruitment

City of Edinburgh

On-site

GBP 100,000 - 125,000

Full time

9 days ago

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Job summary

A leading recruitment firm has an exciting opportunity for an experienced Regulatory Affairs professional with IVDR experience to join a company based near Edinburgh. The ideal candidate will have a relevant degree, previous regulatory experience, and knowledge of CE and FDA regulations, specifically in preparing PMA, BLA, and/or 510k submissions. This role is a key position in ensuring compliance within an FDA licensed manufacturing facility.

Qualifications

  • Experience with IVDR.
  • Previous regulatory experience.
  • Experience working in FDA licensed environments.

Skills

IVDR experience
Knowledge of CE regulations
Knowledge of FDA regulations

Education

Relevant degree in regulatory affairs
Job description

Stem Recruitment have a fantastic opportunity for an experienced RA professional with IVDR experience to work for a IVDR company based near Edinburgh.

The requirements include the following.

  • Experience with IVDR
  • A relevant degree and/or relevant work experience in a regulatory affairs environment.
  • Previous regulatory experience
  • Experience of working within an FDA licensed manufacturing facility.
  • Knowledge and practical experience of CE and FDA regulations, including the preparation of PMA, BLA and/or 510k submissions.
  • Experience of working within an FDA licensed manufacturing facility.

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