Dipl.-Ing. Dieudonne Mbarga

- Manage portfolio of assigned projects and provide functional expertise in area of responsibility for medical devices and combination products - Provide Quality and Regulatory guidance in development projects of combination devices - Write, review and approve deliverables to ensure GMP compliance - Release of medical devices for clinical studies and commercial use - Perform inspections and audits

Field of action as auditor: - ISO 13485 Certification Audits - GMP Audits - CE- Conformity Assessment (MDR /MDD Audits) - Technical File Review

Field of action as auditor: - ISO 13485 Certification Audits - MDSAP Audits - CE- Conformity Assessment (MDR /MDD Audits) - GMP Audits - Technical File Review

- Provides regulatory support for R&D product development - Technical documentation submission for market launch - Regulatory strategies to guide regulatory submission pathways to ensure optimized sequencing for submissions - Product Security Risk Management procedure, activities and documentation for connected device - Lead the Product Safety Risk Management activities and documentation

Write Usability Engineering Procedure and Templates compliant to IEC 62366-1:2015 Chap. 5 & Annex C; Write Usability Engineering Files for Products DHF Update DHF documentation according to ISO13485:2016, MDR, QSR, MDSAP and Regulatory Requirements from countries; Write Regulatory Documentation for Product Certification; Improve and Perform Risk Management according to ISO14971

- Quality Assurance Manager for the R&D project - Drive the team for the R&D documentation through the R&D phases - Lead the writing of the technical documentation for the project (Product Req Spec., SRS, HWRS, SWRS, etc.…) - Work to have the strategy established to achieve the product CE-Marking and 510(K) - Lead the review of the product technical documentation - Write Risk Management documents (DFMEA, Risk Analysis, PFMEA, all risk reports) - Write the quality documents for the project

Project lead for Unique Device Identification/Direct Part Marking (DPM); Project Lead for the Direct Part Marking for Navigation; Products Portfolio; Write the project strategy plan and the project documentation; Lead the review of the product technical; documentation (product drawings, DHF, etc…); Lead the change requests for implementing the DPM for the Navigation Products Portfolio; Work with R&D, Manufacturing, Quality and Regulatory Affairs to review and approve the DPM documentation

Philips (Eindhoven, Netherlands) / mechanical & electrical devices (class II) Quality Project lead for Development project

Management of the manufacturing product quality for both internal and external manufacturing facilities

Regulatory Affairs Manager

Project Lead for DHF remediation project

Projekt Management

Project Lead for auditing, process improvement, risk management; calibration; inspection, testing, Manufacturing processes, CAPA, NCR, SOPs writting

Projekt Management, Qualification and validation of production facilities (URS, DQ, IQ, OQ, PQ), CAPA and NCR issues solving, root cause analysis and resolution actions, etc...

Optimization of the QM System according to ISO 13485, 21CFR Part 820 and 21CFR Part 11, Writting of SOPs, Work Instructions and forms for the QMS. Auditing, Corrective and Preventive Action Process

R&D Projekt Management. Create medical device product concept of with surgeons at hospitals, Writing of the product technical specification, Testing and improvement of products prototypes, Performance of the Design FMEA, Work with the clinical trial team, Complete the technical documentation

Create User requirements specification for medical device, Writing of the product technical specification, Testing and improvement of products prototypes, Performance of the Design FMEA, Work with the clinical trial team, Complete the technical documentation

Management, Marketing, Finance, Leadership

mechatronics and life sciences