Regulatory Affairs Specialist

1 month ago


Belfast, United Kingdom HIRANI Full time
Senior Specialist – Regulatory Affairs (IVD/CDx)

Hirani ARC Regulatory seeks highly skilled and experienced regulatory professionals to join our team.

The Role:

  • Provide specialized regulatory expertise to client companies, ensuring compliance with internal procedures and client expectations.
  • Conduct thorough research and prepare regulatory submission documents for client organizations, including IVDR Annex XIV applications and 510(k) submissions.
  • Support the set-up, management, and conduct of IVD performance studies/clinical investigations worldwide.
  • Stay up-to-date on global regulatory requirements for IVD devices and maintain our clinical trial planning tool.
  • Prepare gap analyses and associated reports for client companies.
  • Contribute to the preparation of other regulatory documents, such as Performance Evaluation Plans/Reports.

We offer a competitive salary range of $120,000 - $150,000 per year, depending on experience.

This is an exciting opportunity to work with a reputable company like Hirani and contribute to the growth of our regulatory department. If you are passionate about regulatory affairs and have a strong track record of success, we encourage you to apply.



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