Expert in IVD/CDx Development

1 month ago


Belfast, United Kingdom HIRANI Full time
Regulatory Expert – IVD/CDx Development

Hirani ARC Regulatory is seeking an experienced regulatory professional to lead our IVD/CDx development efforts.

About the Job:

  • Develop and implement regulatory strategies for client companies, ensuring compliance with global regulations.
  • Prepare regulatory submission documents, including IDE submissions and PMDA Briefing Documents.
  • Manage and maintain our clinical trial planning tool, ensuring up-to-date information on global regulatory requirements.
  • Conduct gap analyses and prepare associated reports for client companies.
  • Design and deliver formal client presentations, highlighting proposed solutions and regulatory support offerings.

With a competitive salary range of $130,000 - $160,000 per year, based on experience, this is an excellent opportunity to grow your career in regulatory affairs and work with a reputable company like Hirani.


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