Teneriffe, Queensland, Australia
Adept leader with well over 20+ years of experience in international medical device/IVD quality & regulatory systems with further experience in pharmaceutical, nutraceutical, cosmetics, product development and implementation of Quality management systems. My work emphasises quality & regulatory knowledge, audits, product life cycle including PMS, design development and product requirement definition, ensuring adherence to not only required regulatory standards, but rigorous industry standards while driving quality initiatives forward. My personal mission is to enable organisations to achieve regulatory compliance and operational excellence with a Quality driven mindset through strategic planning and effective collaboration.
BrandwoodCKC provides comprehensive regulatory, technical, and market access consultancy to help businesses succeed globally. They specialise in strategic planning, product development, and complex submissions across Australia, New Zealand, Asia-Pacific, North America, and Europe. Our end-to-end support covers everything from QMS and technical assessments to post-market compliance and regulatory appeals.
Delivered extensive experience in quality and regulatory affairs within the fast-paced consumer goods sector. I have served as a cross-functional liaison, driving strategic implementation through robust design controls and aligning product development with global standards. My expertise includes updating regional labelling and testing requirements for the US, Japan, and European markets, alongside managing end-to-end compliance through CAPA systems, customer complaint investigations, and internal/external audit schedules.
Led the ground-up establishment of the QC Laboratory, transforming it from a startup phase into a fully operational department. I managed the end-to-end quality lifecycle, including supervising and training technical staff, developing work schedules, and overseeing the inspection of raw materials, in-process goods, and finished production retains. My role was pivotal in maintaining high-level compliance through rigorous audits, root cause analysis, and CAPA/NCR investigations. I also drove continuous process improvements, collaborating with various other departments.
Arch Consulting is a premier third-party consultancy providing expert leadership in regulatory, clinical, and quality affairs across the USDA, OSHA, and FDA-regulated sectors, including cosmetics, biotechnology, and medical devices. We specialise in delivering strategic advice for bringing novel technologies to the US and EU markets, with deep clinical expertise in fields such as orthopaedics, cardiology, and minimally invasive surgery. Our comprehensive service suite covers the entire product lifecycle—from regulatory submissions (510k, PMA, Design Dossiers) and clinical study management to ISO 13485/QSR quality system design, risk management, and direct FDA negotiations regarding audits and warning letters. Whether managing active implantables or ultrasonic imaging systems, we provide tailored support in procedure writing, training, and compliance to ensure our clients succeed in complex global markets.