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RESUMÉ

Product Registration Experience

  • TGA registrations (> 500)

  • TGA Free Sale Certificates

  • TGA conformity assessment certifications

  • Prostheses (reimbursement) listings

  • US FDA 510(k) clearances and PMA supplements/amendments

  • European CE marking

  • New Zealand Medsafe (WAND) notifications

Quality Systems Experience

  • Quality management systems development

  • Training

  • Auditing

  • Quality project plans

  • Design controls

  • Risk management

  • Clinical evaluation reports

Other Experience

  • Product development roadmaps

  • Regulatory plans

  • Market requirements analysis

  • Submission writing

  • Product manuals and labels

  • Managing device recalls

  • TGA annual reports

  • Adverse event reporting

  • Guest lecturer “Foundations Bootcamp - Medical Devices”,
    an MTP Connect program

  • Guest lecturer "Regulatory Affairs in the Medical Device Industry",
    School of Biomedical Engineering, University of Sydney

  • Co-inventor on 103 granted patents

2009 to Present

  • Head Regulatory Affairs, Clinical & Marketing - CathRx

  • CONSULTANT working collaboratively with Dr Derrick Beech, ex-director of the TGA and principal of Medical Technology Consulting. Worked with over 150 Australian medical device distributors and manufacturers assisting with their product registration and reimbursement needs.

1997 to 2009 - ResMed Ltd

  • Regulatory Affairs officer

  • Regulatory Affairs Manager

  • Product Manager - Bilevel Products

  • Product Manager - Masks Division

  • Director Product Marketing - Masks SBU

The Early Years

  • Bachelor of Science,
    Macquarie University

  • Scientific Officer,
    Douglas Laboratories (Pathology)

  • Scientific Officer,
    Oliver Latham Laboratory,
    Macquarie Hospital

  • Product Specialist/Manager
    Amersham Australia

  • Sales Territory Manager,
    Bayer Diagnostics

  • Regulatory Affairs officer,
    Telectronics

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