Ellen Hellmoldt is a Quality Assurance professional with 20 years of experience in GCP, GLP, and GMP regulatory compliance, specializing in the medical device industry. Throughout their career, Ellen has held positions such as Sr. QA Engineer at Asante Solutions and Teleflex Medical OEM, and Regulatory Compliance Manager at BD Biosciences. Ellen is currently a Principal Engineer in Quality Management Systems at Stryker and is pursuing a Bachelor of Science in Medical Technology at Philippine Women's University. Their extensive knowledge includes FDA regulations, ISO standards, and ICH guidelines.
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