Niamh S.

Medical Device Regulatory Affairs, Software, AI and Risk Management expert. TC contributing member for Ireland on IEC 62304, IEC 63450 and AI Advisory Group SNAIG, TC10 Chair for Ireland, Task2 (AI) for CEN-CENELEC

Galway, County Galway, Ireland

About

30 Years' experience in IT, Pharmaceutical and Medical Device industries within UK, Switzerland and Ireland. Highly educated and motivated. Expert in Medical Device Regulations, QMS, Risk Management, SaMD and AI

Experience

  • PhD Researcher of AI-enabled Medical Devices, Regs and Standards, & P/T Lecturer Software Validation at Dundalk Institute of Technology
    Sep 2023 - Present · 2 yrs 7 mos

    AI-enabled Medical Device; Standards Development in Software (IEC 62304 Ed2) AI (IEC 63450) with IEC and ISO Technical Committees on behalf of Ireland and NSAI

  • Founder at St John Lynch & Co.
    Jun 2023 - Mar 2026 · 2 yrs 10 mos

    Regulatory AI Software Engineering and Regulatory Services to the MedTech Industry.

  • Director QA/RA at SymPhysis Medical
    Oct 2024 - Jun 2025 · 9 mos

  • Director of Regulatory Affairs and Quality at Caldera Medical
    Apr 2022 - Sep 2023 · 1 yr 6 mos

    Regulatory Software Cybersecurity 510k

  • Veryan Medical (Full-time · 2 yrs 2 mos)
    • Senior Design Assurance Manager
      Feb 2021 - Apr 2022 · 1 yr 3 mos

    • Regulatory Affairs Manager
      Mar 2020 - Feb 2021 · 1 yr