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Jason Bilobram


Vice President, QA, Compliance & Regulatory
Sekisui Diagnostics
Austria

Biography

Jason has worked in Quality Assurance and Regulatory Affairs for more than 20 years with leadership roles in both the Medical Device and Pharmaceutical industries.   He joined Sekisui Diagnostics in 2015 and is responsible for ensuring global compliance with relevant laws, rules and regulations. This includes Quality Management Systems, Good Manufacturing Practices, Regulatory Compliance, and Post-Market Surveillance.  Prior to joining Sekisui Diagnostics, Jason served in a variety of Quality and Regulatory roles at Smith-Nephew Inc., most recently as Global Director of Safety Affairs, where he was responsible for various programs within Quality Assurance and Regulatory Compliance across multi-site, domestic and international operations. Jason holds a B.S. in Biochemistry from the University of Rhode Island and is completing his thesis in Molecular Biology with sponsorship from both Brown University and the University of Rhode Island.  He has achieved his Regulatory Affairs Certification (RAC) as well as holding a Green Belt Certification.  He is a member of AdvaMed DX and AAMI acting as an industry advocate for various committees and work group

Research Interest

PHARMA

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