Patricia Byrne

Trisha brings over 16 years of experience in Regulatory Affairs within the medical device industry. Leveraging this extensive background, she has successfully transitioned into Project Management, where she now supports the planning and execution of complex pharmaceutical development programs. 

Throughout her career, Trisha has worked with leading medical device companies in Europe and the US, covering therapeutic areas such as orthopaedics, wound and acute care, obesity intervention, patient monitoring, and implantable devices. Her hands-on experience with audits (ISO 13485, MDSAP, and MDD), CE marking, and international submissions enriches her approach to managing stakeholder expectations and driving regulatory-aligned deliverables. 

In her previous positions, Trisha specialised in European Regulatory Affairs, CE marking a diverse range of medical devices, from Class I through to Class III, in addition to completing regulatory submission in various international markets.