Fil Buenviaje

  • Posted on Nov 22, 2017 at 19:04

Fil Buenviaje 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 WCG Cares in 2015 and is responsible for ensuring supplier quality, product quality and global regulatory compliance with relevant laws, rules and regulations. This includes Quality Management Systems, Good Manufacturing Practices, Regulatory Compliance, and Post-Market Surveillance.

Prior to joining WCG Cares, Mr. Buenviaje served in a variety of Quality and Regulatory roles most recently as Director of Quality Assurance at Sequenom Biosciences.  He brings with him extensive experience as a Quality/Regulatory leader supporting development, manufacturing, quality and regulatory activities from his tenure at firms:  Quidel, Biosite, Genzyme Diagnostics and TÜV Product Service.  Mr. Buenviaje has achieved certifications as a European Notified Body Medical Auditor, a Canadian Medical Devices Conformity Assessment Systems (CMDCAS) Qualified Person, ISO 9001 and ISO 13485 Lead Auditor and Regulatory Affairs Certification (RAC-US).  He has also successfully obtained product registrations with U.S., Canada, European, Asia and Latin America regulatory authorities.