Accomplished, analytical, and highly organised QMS auditor and Regulatory Affairs management professional with over 20+ years of frontline experience successfully overseeing the product development, manufacture, compliance, pre-market and post-market support ensuring stringent adherence to consecutive applicable regulations and quality standards across diverse range of medical devices, invitro diagnostics devices, drug-device combination products, OTC and POM formulations with performing high grade research and market analysis. Possess extensive knowledge and on-hands experience handling regulatory submissions to various world markets, broad experience of implementing international standards for quality management complying to the market regulations. Demonstrated ability to organise, optimise - workflow supported by extensive experience, maintaining, updating quality management system from policy level to process controls and implementation of metrics to give foundation to Organisation’s KPI / objectives. Leverage strong ability to proactively identify issues and orchestrate corrective measures and solutions with efficient time management for business needs. Proactive and open minded to learn further in product design and development, regulatory, quality assurance, clinical trials arena and various business strategic and aspire to handled senior management portfolio specialising in life science industry.
Menlo Park, CA, USA
September 1998 - Today (25 years and 2 months)
If I had to sum up my life up to this point, I'd say it's been one heck of a ride...