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Regulatory Affairs Specialist

Regulatory Affairs Specialist

  • Full Time
  • Clare

Regulatory Affairs Specialist

About the Employer:

Our client, a global diagnostics company, is currently recruiting a permanent Regulatory Affairs Specialist with experience in the quality/regulatory area within a manufacturing facility. Liaising directly with the Regulatory Manager, this role will involve activities relating to Product Corrective Action letters, Agency reporting and Field Safety Notice. This position is located in Clare.

Our client offers a competitive remuneration package along with career progression for motivated and driven individuals along with excellent working conditions.

As a Regulatory Affairs Specialist, some of your duties and responsibilities will include:

  • Approving printed material from regulatory affairs perspective.
  • Implementing regulatory system requirements as per IVD Directive ISO13485 and FDA QSRs.
  • Providing advice on all regulatory affairs when requested.
  • Advising project teams on regulatory requirements.
  • Developing and implementing the regulatory strategy
  • Participating in internal and external audits.
  • Participating in quality and environmental system reviews.
  • Proposing device modifications for the Corporate RA.

The Successful Candidate:

  • Will have a minimum of B.Sc. level in a scientific field or relevant technical field.
  • Will have at least 1+ years’ experience in a quality or regulatory role within a manufacturing facility.
  • Will have a knowledge and understanding of ISO13485: 2003 and the FDA QSRs.
  • Will have experience in product registration process.
  • Will have the ability to work in a fast-paced environment with excellent communication skills both verbal and written.
  • Experience of 510K preparation is desirable but not essential.

For further information or if you wish to apply for the position of Regulatory Affairs Specialist, please send your CV in word format to

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