QA/RA responsible for 30+ concurrent medical devices and companies.
Vesna Janic is certified by the Society of Quality Assurance (SQA) as a Registered Quality Assurance Professional in GLP (RQAP–GLP). She is a registered GLP Inspector with the Standards Council of Canada (SCC) and holds a Bachelor of Science degree in Biology and ISO 13845 Lead Auditor certificate. She has 18 years of experience as part of Senior Management team and 10 years as SCC GLP inspector (volunteer position), and 8 years as QA/RA Director in medical devices field.
Currently, Vesna is a Director of Quality and Regulatory Department at StarFish Medical Inc and ViVitro Labs. Prior to joining StarFish, Vesna was an independent QA consultant providing customized Quality Assurance support mainly in quality management systems, training and preparation for OECD GLP recognition inspection. In previous 10 years Vesna was the Director of Corporate Quality Assurance at CANTEST Ltd and Quality Manager at BC Research Inc, where she was responsible for establishing and maintaining quality systems compliant with OECD, EPA and FDA GLP, HC and US cGMP, GCP and ISO/IEC 17025. Her expertise is in regulatory compliance and conformance with standards, not limited to: ISO 13485; quality and regulatory inspections; facility and study audits; gap analysis; CAPA systems; GxP and ISO training; vendor qualifications; document control and archiving. Prior to moving into quality and regulatory field, Vesna was part of the R&D Group at BC Research where her research supported 3 patent applications, one directly as co-inventor. Vesna presented at medical device conferences, Society of Quality Assurance (SQA) conferences and Regulatory Affairs Professional Society (RAPs) seminars.
Over the years, Vesna has attended professional education from RAPs, SQA, ASQ, CSPS, SCC, CALA and various leadership training providers. Vesna is a member of BC Chapter of Regulatory Affairs Professional Society, Society of Quality Assurance and PRC Section of SQA.