Regulatory and Product Development
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Innovative scientist with extensive experience in the medical device industry. In-depth exposure to regulatory compliance across various territories (EU, USA, China, Indonesia, South Africa). Strong research background in Environmental Science and Microbiology. Experienced in managing device technical files, registration and certification of medical devices, validation of Ethylene Oxide sterilization plants, biocompatibility and packaging stability testing and medical device product development.
Regulatory Affairs, Product Development, Quality Assurance
