Senior Regulatory Specialist

3 weeks ago


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

We are looking for a seasoned Regulatory Affairs Senior Associate to support our clients in the life sciences sector.

The role:

  1. Collaborate with project teams to provide specialized regulatory expertise, ensuring that client expectations and interests are met.
  2. Utilize extensive experience in IVD/CDx development, validation, and approval to offer expert strategies and guidance to client organizations.
  3. Prepare regulatory submission documents, including IVDR Annex XIV applications, CTAs, study risk determination requests, IDE submissions, 510(k), PMA, CE Technical Files, and Design Dossiers.
  4. Support the team in understanding regulatory requirements for investigational devices in the setup, management, and conduct of IVD performance studies/clinical investigations worldwide.
  5. Maintain our web-based clinical trial planning tool and manage information relating to global regulatory requirements for IVD devices.
  6. Conduct gap analyses and prepare associated reports on behalf of client companies.
  7. Contribute to the preparation of other regulatory documents, such as Performance Evaluation Plans/Reports and Investigator Brochures.

The estimated salary for this position is around $100,000 - $130,000 per year, depending on experience and location. We offer a range of benefits, including comprehensive health insurance and retirement plans.



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