Fiona Campbell

Fiona J Campbell, MSc

HRB CRCI Clinical Industry Liaison Officer

Fiona graduated in 1993 with a B.Sc. Honours in Biochemistry and in 1994 with a MsC in Food Science from UCD. She started her career in Quintiles, Ireland where she did CRO regulatory Affairs work.  She then Joined Trinity Biotech as Regulatory Affairs Manager.  During this time, she successfully gained PMA approval for a rapid HIV test and CE marked over 200 products.  Fiona than went solo and provided regulatory and quality consultancy for medical device and pharma start-up companies.

Moving then to Abbott/Abbvie and Pfizer as medical affairs manager in local and global positions. In these companies Fiona lead large muti-country research studies and coordinated many scientific publications gaining expertise in infectious disease, neonatology, nephrology and vaccines.

Fiona was appointed Clinical Industry Liaison Officer, HRB-CRCI in December 2018.  The primary purpose of her role is to support clinical investigation and performance evaluation of medical devices and in-vitro diagnostic products in Ireland.

Fiona’s Mission Statement:  Define a plan with an in-field approach, to address needs and gaps in current regulatory, quality, research and clinical environment, so that Irish MedTech start-up companies, have a more efficient route to clinical investigation, benefiting Irish patients and facilitating a faster route to market for their products that support unaddressed patient needs.

Examples of how Fiona can help:

  • Advice on early stage product classification
  • Regulatory pathway development advice
  • Signposting on QMS; requirements for start-up companies
  • Advice on Design Control and Risk Management while developing Medical
  • Devices
  • Linkages to information resources
  • Support services to Clinical Research facilities
  • Advice on Medical Device Regulations
  • Advice on international standards ISO 13485, ISO 14155, ISO 14971

Email: fiona.campbell@hrb-crci.ie

Phone: +353 85 8591227