QA, Program Management & Regulatory Intelligence Expert
Tran brings to Qserve more than 15 years of experience Quality Management Systems Development and Process Improvement, Regulatory Compliance, Regulatory Intelligence, as well as Internal and External Inspection/Audit Readiness Activities.
The key expertise areas of Tran
- Quality Management System (ISO 13485:2016, FDA 21 CFR 820, FDA 21 CFR 210/211, FDA 21 CFR 11)
- EU MDR
- Medical Device Directive (i.e. 2.7.1, 93/42/EEC, Brazil ANVISA Medical Device Regulations, Canada SOR/98-282, MDSAP, and Japan MHLW Ord. 169).
- Certified six sigma greenbelt who have had extensive Project Management experience
- ISO 13485 lead auditor.
About working at Qserve
“I feel extremely fortunate to be part of such a highly qualified and competent global medical device consultancy team. It is refreshing to know that team members value and respect each other’s input and expertise. The wealth of knowledge and experience in this organization is astounding. Working for a company that promotes teamwork and continuous employee development is a great plus.”
Before joining Qserve, Tran was the Americas (AMS) Regulatory Regional Manager where she managed the AMS team of regulatory professionals to support new product registrations and renewals for Canada, US, and Latin America. She was also the owner of the Regulatory Intelligence Program where she developed the regulatory intelligence systems to capture global market requirements and efficient regulatory practices to accelerate product market access.
Prior to moving into Regulatory, Tran was responsible for the Inspection/Audit Readiness activities and lead various Quality Management System improvement projects (for a multi-site, international organization). She also managed projects with global cross-functional teams to implement a compliant electronic system for paper-based processes (such as CAPA, Internal Audit, Supplier Audit, Nonconformities, and Design History File).
Tran has held various positions in small and large medical device companies, ranging from Biologics, Pharmaceutical, Combination Products, as well as Capital Equipment medical devices (radiotherapy). Tran also has extensive experience in advancing product innovations from concept through product launch working with cross-functional, global project teams, and internal/external customer to consistently drive improvement and project deliverables.
Learn more about our services within Quality Assurance & Regulatory Affairs.
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