Senior Vice President, Regulatory and Quality
Meera Juneja has over 20 years of experience in the medical device industry spanning from start-ups to established medical device companies, with special emphasis in the areas of quality assurance and regulatory affairs.
Meera joined Matrix Medical in 2015. During her time at Matrix, she has implemented numerous Quality Management Systems, assisted Clients in achieving CE Marking and FDA Clearance for their devices, as well as ISO 9001:2015, ISO 13485:2016 and MDSAP Certification of their Quality Systems. Meera has also provided support for Clients during Notified Body Audits and FDA Inspections, as well as Annual Internal Audits. In addition, she serves as a virtual Quality and Regulatory Lead for several of Matrix’s Clients.
Meera received Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professionals Society (RAPS) in 2017. She also received British Standards Institution (BSI) ISO 13485:2016 Lead Auditor Certification in 2020.
Prior to joining Matrix, Meera served as Director of Regulatory Affairs and Quality Assurance at Complion, Inc.. She led the software validation effort to ensure compliance to 21 CFR Part 11 for electronic records and electronic signatures during the development of a comprehensive regulatory e-System to efficiently manage clinical trial documentation at academic medical centers, community health systems and research sites. Additionally, Meera developed various e-System modules for FDA submissions.
Meera’s prior experience as Manager, Regulatory Affairs at Frantz Medical Development, Ltd., encompassed the responsibility of the company’s Management Representative and regulatory affairs representative for medical device product development cross-functional programs in the areas of interventional cardiology and orthopedics. Meera was also responsible for establishing and maintaining the international and FDA regulatory requirements for the company’s infusion pump and cannula product lines. During her tenure, Meera streamlined and maintained the company’s Documentation Control and Management Review processes. Meera also served as a member of the Corrective Action Board in which she was actively involved in the identification and implementation of corrective and preventive actions. As the Management Representative, Meera was also responsible for leading third-party and ISO/FDA audits and ensuring QSR requirements were effectively established and maintained.
Meera has also held positions at Imalux Corporation, a company focused on pioneering medical imaging devices based on optical coherence tomography, and STERIS Corporation, a global leader in infection prevention, contamination control, surgical and critical care technologies.
Meera received a Bachelor of Science from John Carroll University.