Summary of Experience
Regulatory Compliance: Ensured compliance with US and international regulatory requirements and obtained the appropriate clearance, approval, and licensing of class I and II medical devices.
Established and maintained relationship with the regulatory authorities & affiliates in the US, Canada, European Union, Australia, New Zealand, Singapore, and Saudi Arabia.
Quality Assurance: Developed and maintained Quality Management Systems conformant to the ISO 9001 and ISO 13485 standards and in compliance with medical devices regulatory requirements: FDA 21 CFR 820, EU MDD, CMDCAS and TGA.
Project Management: Led project engineering activities associated with developme...
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