Amy Quan
Regulatory Affairs Specialist at BD
- Role
- Staff Regulatory Affairs Specialist at BD
- Location
- San Clemente, CA, US
- LinkedIn followers
- 500 followers
About Amy Quan
Regulatory Affairs Specialist with years of experience in diagnostic regulations. Knowledge in regulatory guidelines, product submissions, lifecycle management, and more.Led successful transition project of BioMerieux\'s largest regions, Europe, Middle East, Africa (EME-A) with approximately 115 countries for product submissions. This helped to establish strong relationships between subsidiaries and/or distributors. This was successaful due to strong organizational skills, cross-cultural communication, and a positive attitude. Using the skills from product submissions in the EME-A region, I transitioned to product lifecycle management. Collaborating with other team members, we are able to ensure that we have the technical knowledge of products and product changes to ensure product submission are compliant with regulations of different countries and/or jurisdictions. This has been a success because of strong communication, collaboration, and problem-solving. I am passionate about navigating complex regulatory environments and committing to continuous learning of evolving regulations. I\'m continuing my education at the University of Utah to obtain my MBA. Outside of work, I enjoy indoor cycling, reading, and crocheting.
Experience
Staff Regulatory Affairs Specialist
Dec 2025 — Present · CA, US
Education
University of Utah - David Eccles School of Business
Bachelor's degree, Operations and Supply Chain
University of Utah - David Eccles School of Business
Master of Business Administration - MBA, Business Administration and Management, General
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