Regulatory Affairs Specialist

2 months ago


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

Hiranai seeks a highly skilled Regulatory Affairs Senior Associate to join our team. As a key member of our regulatory team, you will provide specialized regulatory expertise to client companies, ensuring that internal procedures and client expectations are met.

The Role:

  • Support the work of our company and project teams in providing regulatory expertise to client companies, ensuring that internal procedures and client expectations are met.
  • Bring considerable experience in IVD/CDx development, validation, and approval to client organizations, providing expert strategies and guidance to their development programs.
  • Research and prepare elements of regulatory submission documents on behalf of client companies, including IVDR Annex XIV applications, CTAs, study risk determination requests, IDE submissions, 510(k), PMA, CE Technical Files, and Design Dossiers.
  • Assist the wider team in understanding the regulatory requirements for investigational devices in the setup, management, and conduct of IVD performance studies/clinical investigations worldwide.
  • Manage and keep up-to-date information relating to global regulatory requirements for IVD devices and maintain our company's web-based clinical trial planning tool.
  • Conduct gap analyses on behalf of client companies and prepare associated reports, such as technical documentation/design history files.
  • Contribute to the preparation of other regulatory documents on behalf of client companies, including Performance Evaluation Plans/Reports and Investigator Brochures.
  • As required, take advantage of professional networking opportunities to promote our company and its services to appropriate parties.
  • Design and deliver formal client presentations, including proposed solutions and client training. Prepare and deliver presentations relevant to our company's regulatory support offerings at industry meetings and conferences.
  • Undertake continuing professional development activity to ensure awareness of current quality and regulatory standards.
  • Contribute to Hiranai company culture initiatives to maintain a positive and engaging workforce.


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