- Manage, monitor and plan projects and resources- Implement and communicate change when necessary to meet project outputs- Manage and implement training plans- Track deliverables and report progress- Collect QC data- Oversee structural projects- Discussing and aligning any processing activities- Assist in maintaining the clinical evaluation & technical file documentation up-to-date and compliant - Assist the QA Officer in handling nonconformities and CAPAs… Show more - Manage, monitor and plan projects and resources- Implement and communicate change when necessary to meet project outputs- Manage and implement training plans- Track deliverables and report progress- Collect QC data- Oversee structural projects- Discussing and aligning any processing activities- Assist in maintaining the clinical evaluation & technical file documentation up-to-date and compliant - Assist the QA Officer in handling nonconformities and CAPAs including those found during audits conducted by regulatory authorities/external clients - Participate in the handling of complaints & vigilance activities as per the procedures - Provide assistance, as required, in nonconformities review, management review, post-market surveillance review, supplier review- Deputy Person Responsible for Regulatory Compliance Show less

- Lead and responsible for the compliance of 1 in 4 modules, which integrates a Software Medical Device in accordance with the Medical Devices Regulations and associated harmonised standards. Planning, execution and documentation of SRS and SDS: Design Controls, Risk Management, Technical Design and V&V testing.- As software functional tester I gather functional requirements working closely with R&D team on design, testing and implementation of new features, providing analysis and… Show more - Lead and responsible for the compliance of 1 in 4 modules, which integrates a Software Medical Device in accordance with the Medical Devices Regulations and associated harmonised standards. Planning, execution and documentation of SRS and SDS: Design Controls, Risk Management, Technical Design and V&V testing.- As software functional tester I gather functional requirements working closely with R&D team on design, testing and implementation of new features, providing analysis and optimization of processes (test plan/test strategy, test cases, test execution and verification reports) applying SDLS methodology. Implementation and optimization of the workflow of the image processing (automatic and manual processes).- Responsible to implement and perform medical image processing by recognizing and identifying anatomical structures from CT scans. Show less