Experience

CYNERGEX GROUP LIMITED

• Australia
• Professional Training and Coaching
• 1 - 100 Employee

• Independent Director

  • Jul 2013 - Present

  Provide guidance in developing and implementing the strategic business plans in relation to organic growth, expansion, profitability, risk, occupational health and safety and operations in the field of Emergency Medicine services and training. Provide guidance in developing and implementing the strategic business plans in relation to organic growth, expansion, profitability, risk, occupational health and safety and operations in the field of Emergency Medicine services and training.



Bio Diligence

• Sydney, Australia

• Prinicipal and Senior Consultant

  • Sep 2011 - Present

  Provide cGMP/QMS, Regulatory Affairs, Design and Development, Technical Writing and Consulting services primarily to clients in the medical device, in vitro diagnostics and combination product (drug/device) landscape. Mentoring and guidance to biotech companies on regulatory landscape, strategy, technical requirements, standards and regulated manufacturing. Provide cGMP/QMS, Regulatory Affairs, Design and Development, Technical Writing and Consulting services primarily to clients in the medical device, in vitro diagnostics and combination product (drug/device) landscape. Mentoring and guidance to biotech companies on regulatory landscape, strategy, technical requirements, standards and regulated manufacturing.



Leveltec Engineering Pty Ltd

• Australia
• Mining
• 1 - 100 Employee

• General Manager / CFO

  • Mar 2018 - Aug 2022

  General Manager and now CFO of a specialised Australian manufacturer supplying engineered electro-mechanical solutions to mining and heavy industries. General Manager and now CFO of a specialised Australian manufacturer supplying engineered electro-mechanical solutions to mining and heavy industries.



PharmaLex Formerly Brandwood CKC

• Australia
• Government Relations Services
• 1 - 100 Employee

• Senior Regulatory Affairs Consultant / Operations Manager

  • Jan 2012 - Oct 2016

  Senior consulting to clients covering design and development, new product commercialisation, cGMP systems, risk management and regulatory affairs covering key market jurisdictions for medical devices, combination products and in vitro diagnostics. Strategic input and management of all aspects of the daily and long term operations and resource planning. Senior consulting to clients covering design and development, new product commercialisation, cGMP systems, risk management and regulatory affairs covering key market jurisdictions for medical devices, combination products and in vitro diagnostics. Strategic input and management of all aspects of the daily and long term operations and resource planning.



Tyrian Diagnostics Limited

• Biotechnology Research
• 1 - 100 Employee

• Chief Operating Officer

  • Mar 2009 - Sep 2011

  Commercialisation of rapid PoC Lateral Flow IVDs and software (including design verification/validation), technology transfer, scale up, regulatory approvals and all commercial manufacturing operations (outsourced). Commercialisation of rapid PoC Lateral Flow IVDs and software (including design verification/validation), technology transfer, scale up, regulatory approvals and all commercial manufacturing operations (outsourced).



Unilife Corporation

• Harrisburg, Pennsylvania Area

• Director of Corporate Quality and Regulatory Affairs

  • Jan 2004 - Feb 2009

  Managing all aspects of quality, regulatory and GMP compliance (products and processes) throughout the product life cycles and accomplishing and maintaining regulatory approvals in Australia, EU, US and Canada. Responsible for both Australian and US operations, based in the US subsidiary for 2.5 years. Managing all aspects of quality, regulatory and GMP compliance (products and processes) throughout the product life cycles and accomplishing and maintaining regulatory approvals in Australia, EU, US and Canada. Responsible for both Australian and US operations, based in the US subsidiary for 2.5 years.



Unomedical / Maersk Medical

• Sydney, Australia

• Quality and Regulatory Manager

  • Oct 1998 - Dec 2003

  Responsible for managing all aspects of the quality and regulatory functions within the Australian division, as well as ensuring ongoing compliance to of products and processes to regulations. Responsible for managing all aspects of the quality and regulatory functions within the Australian division, as well as ensuring ongoing compliance to of products and processes to regulations.