- Led the implementation of QMS (ISO 13485)- Managed QMS processes (Document Control, calibration and maintenance etc)- Conducted management review meetings as the management representative- Developed regulatory strategy for the US (Class II) and EU (Class III) medical device- Compiled and inducted procedures for key processes Document Control, Risk Management, Calibration and maintenance activities, control of records, product identification & traceability etc. - Supported the R&D team in determining and implementing regulatory requirements- Investigated eQMS platforms based on company needs.

- Quality System and Regulatory Management for Class II and Class III Devices (Catheters and heart valves) - Compile and review technical documents for Class II medical devices (FDA requirements for 510K)- Compile FDA submission dossier and conduct Pre-Sub Meeting - Responsible for Technical File Management - Audited as per ISO 13485- Manage Clinical Study Requirements (South Africa) - Conduct CAPA investigations and implement improvement actions

- Implement and oversee risk management activities for Class III Medical Devices per ISO 14971- Build product technical files as per design and development procedure and ISO 13485 (Verification and Validation Activities)- Pre-clinical data review and analysis for regulatory reporting using GLP - Compile and maintain Clinical Evaluation Dossier for regulatory requirements - CAPA methodology and root cause analysis - Assist in implementing product traceability and identification processes and implement QMS processes- Design and Develop stent post-processing procedure (Create SOPS and reports)