Dieudonné M.
PRRC, Quality and Regulatory Representative
Experience
Feb 2021 - Present
4 years 7 monthsSingapore
PRRC, Quality and Regulatory Representative
Biofourmis AG
- Manage portfolio of assigned projects
- Provide Quality and Regulatory guidance in product development projects
- Lead the R&D team in the writing of the MDR/FDA technical documentation
- Perform inspections and audits
- Ensuring QMS and technical documentation compliance with relevant standards and regulations such as ISO 13485 (QMS), EU/2017/746/IVDR, and 21 CFR Part 820
- Monitoring regulatory updates and ensuring the QMS reflects current requirements.
- Write clinical Evaluation plans and reports
Feb 2021 - Present
4 years 7 monthsSwitzerland
Consultant Auditor
SGS Switzerland
- ISO 13485 & ISO 9001 Certification Audits
- MDD surveillance Audits
Dec 2020 - Jan 2021
2 monthsSweden
RA/QA Specialist
ImmunoIVD
- Planning Technical documentation update for transition IVDD to IVDR
- Update Technical documentation and prepare techfile review by Notified Body
- Lead the team for the readiness of the IVDR CE Conformity Assessment
- Provide guidance for Products development to R&D Team
Jun 2020 - Jan 2021
8 monthsOslo, Norway
RA/QA Specialist
NEC Oncommunity AS
- Planning Update QMS for transition IVDD to IVDR
- Perform Gap assessment on the QMS and Technical documentation against IVDR
- Remediation of CE-Technical documentation and provide strategy for FDA approval
- Update the IVDD technical documentation to comply with IVDR requirements
- Establish ISO 13485 Quality Management System and improve the procedures
- Provide guidance for Products development to R&D Team
May 2020 - Dec 2020
8 monthsSwitzerland
Quality Assurance Specialist
Novartis Pharma
- 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 (e.g. procedures, records, third party work, clinical trial material, components) to ensure GMP compliance
- Support Medical Device Risk Management, through proactive risk management tools and approaches, to minimize impact on global supplies and patients
- Release of medical devices for clinical studies and commercial use
- Perform inspections and audits
Apr 2020 - Present
5 years 5 monthsGermany
Consultant Auditor
TÜV NORD CERT GmbH
- ISO 13485, MDR Certification Audits
- MDD surveillance audits, MDSAP Audits
- CE- MDR Conformity Assessment Audits
- Technical File Review
Sep 2019 - Jul 2020
11 monthsBonaduz, Switzerland
Regulatory Affairs Specialist
Hamilton Medical AG
- Provides regulatory support for R&D product development to ensure compliance to regulatory requirements for desired markets around the globe.
- Works to prepare and submit technical documentation to regulatory authorities for obtaining authorization for market launch.
- Develops regulatory strategies to guide regulatory submission pathways, taking into consideration regulatory requirements (including product testing, clinical data, etc.), product claims and country priorities to ensure optimized sequencing for submissions.
- Write the Product Security Risk Management procedure.
- Perform the Product Security Risk Management activities and documentation for connected device.
- Lead the Product Safety Risk Management activities and documentation.
- Write the Product biological safety evaluation.
- Write and support the achievement of the product clinical evaluation report.
- Support the usability activities and write the usability Engineering File.
- Review the Design and development documentation, support and guide R&D Team.
Aug 2019 - Present
6 years 1 monthGermany
Consultant Auditor
DQS Notified Body
- ISO 13485 Certification Audits
- MDD surveillance audits, MDSAP Audits
- CE- MDR Conformity Assessment Audits
Dec 2018 - Jun 2019
7 monthsUnterschleißheim, Germany
Quality Assurance Specialist (R&D, QA/RA)
Philips/TomTec
- 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
- Determine gaps in processes / instructions, in particular development according to IEC 62304 as well as strategy, planning and implementation of changes in this regard
- Preparation and consultation / monitoring of audits
- Process complaints and CAPAs
- Supplier Management (ISO IEC 17025 - Test equipment, calibration)
Feb 2018 - Dec 2018
11 monthsKornwestheim, Germany
Products Risk Manager (R&D, QA/RA, Manufacturing Project)
Roche Invitro Diagnostics
- Lead and co-ordinate Risk Management activities involving interaction with various departments.
- Lead the writing of the DFMEA for new product development.
- Provide guidance to team on risk management, regulatory and quality engineering policies, principles and best practices.
- Lead the upkeep/maintenance of Risk documents maintained within the quality management system.
- Ensure all risk management activities and documentation are compliant with all relevant risk management regulations.
- Lead the remediation of the noncompliance issues within the Risk Management Files and ensure documents are updated where required.
- Train Employees to the Risk Management Process according to ISO 14971.
Jul 2017 - Jan 2018
7 monthsAu, Switzerland
Quality Assurance Specialist (R&D, QA, RA Project)
Lyca Microsystems
- Quality and Regulatory guidance for R&D projects
- Drive the team for the R&D documentation through the R&D phases
- Remediation of DHF files. Improve the product documentation of product portfolio
- GMP and Corporate Audits Support
- QMS optimization (Improvement of Product Development Procedure, Engineering Change Procedure, Risk Management procedure, Verification and Validation Guidance)
- Write Usability Engineering File according to IEC 62366
- Perform design reviews for R&D projects
- Deal with all R&D department CAPAs
Dec 2016 - Jun 2017
7 monthsAalen, Germany
Quality Assurance Specialist (R&D Project)
Carl Zeiss
- 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
Jan 2016 - Dec 2016
1 yearFreiburg im Breisgau, Germany
Project Manager for UDI (Unique Device Identification)
Stryker
- Project leader for Unique Device Identification/Direct Part Marking (DPM)
- Compose the project strategy plan and the project documentation
- Lead the review of the product technical documentation (product drawings, DHF, etc…)
- Update Risk Management documents
- 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
- Update the DHF for the Navigation Products Portfolio
- Update Technical documentation for certificates
Jan 2015 - Sep 2015
9 monthsEindhoven, Netherlands
Quality Assurance Manager
Philips
- Quality Project lead of Development project
- Writing of the regulatory requirements for the project
- Writing the supplier quality requirements contract for the new product (suppliers’ approval)
- Working with clinical team for establishing the clinical strategy for 510 (k) submission
- Driving the Team for completing the technical documentation
- Leading the R&D milestones tasks
- Create the project structure for the assigned scope, organize tasks and assign responsibilities to project team
- Analyse failures in DHF, develop with team appropriate solutions for non-conformities in DHF
- Write Regulatory documentation for Certification
- Update Technical documentation for certificates in Asia and Latin America
- Write & Perform Risk Management (DFMEA, User FMEA) for R&D project
- Solve CAPA and NCR on existing products
Jun 2014 - Mar 2015
10 monthsBerlin, Germany
Project Manager DHF Remediation
Leoni AG
- Create the project structure for the assigned scope, organize tasks and assign responsibilities to project team
- Writing of the regulatory requirements for the project
- Analyse failures in DHF, develop with team appropriate solutions for non-conformities
- Design with concerned departments, resolution plans for failures found and implement them.
- Initiate and implement the solution through CAPAs
Mar 2014 - Jun 2014
4 monthsZuidland, Netherlands
Quality Management System Expert
D.O.R.C.
- Assess the Quality Management System regarding the Validation Process
- Improve the Quality Manual regarding the Validation Process
- Write the procedures (SOPs, work instructions and forms) for the Validation Process
- Assess the Risk Management Process and set Requirements for Improvement
- Train employees in new procedures
May 2013 - Jun 2014
1 year 2 monthsZuchwil, Switzerland
GRQP Subject Matter Expert (Project Leader)
Johnson&Johnson
- Process Improvement (Risk Management; Calibration; Inspection, Test and Release; etc...)
- Writing SOPs and work instructions
- Updating Risk Management File
- Update Manufacturing Processes
- Writing the legacy review reports (audit reports) and the remediation plans (recommendation plans how to resolve the deviations and noncompliance found in the legacy review).
Feb 2012 - Jun 2013
1 year 5 monthsBeringen, Switzerland
Project Lead Manufacturing Engineer
Abbott Vascular Ltd
- Implementation of R & D projects in production.
- Provide technical assistance to the production teams for the entire project phase.
- Process optimization.
- Production optimization and products developed in collaboration with R & D.
- Write and Perform Risk Management (Risk Analysis, PFMEA).
- Qualification and validation of production facilities.
- Training of production staff.
- Audit preparation and presentation of production issues.
- Production documentation control.
- Computer System Validation.
- Led Balloon Blow Process optimization project: Six sigma project (optimization of the balloon yield).
- Led CAPA on pinhole issue project (team of 5 engineers): Initiation, investigation and implementation phases.
- Led CAPA on extrusion validation issue for tubing process project (team of 6 engineers): Initiation, investigation and implementation phases.
- Led Qualification of the extrusion equipment project (team of 2 engineers, 22 machineries): Equipment Installation qualification, Equipment Operation Qualification.
- Led Validation of the extrusion tubing process project (team of 6 engineers): Developer of the Validation Strategy and the Validation Plan, Writing of the process FMEA, Participating in the performance of the risk analysis of the extrusion process, Writing of the OQ and PQ plans, Performance of the OQ and PQ runs, Writing of the OQ, PQ and Extrusion reports.
Jun 2010 - Dec 2011
1 year 7 monthsPlochingen, Germany
Quality Assurance Engineer
Ceramtec GmbH
- Document Management System Administration.
- Update the Document Management System Software.
- Revision and Correction of Quality documents.
- Conducting Internal Audits and supplier audits.
- Supplier Qualification.
- Supplier Management (including ISO IEC 17025 - Test equipment, calibration).
- Testing and inspection (AQL ISO 2859-1 and ISO 16269-1).
- Writing SOPs.
- Writing Work instructions.
- Writing forms.
- Led QM System Optimization project (ISO 13485, 21CFR Part 820, 21CFR Part11).
- Improved Documentation Control process.
- Improved Internal Audit Process.
- Improved Corrective and Preventive Action Process.
- Improved Quality Control Process.
- Improved Risk management process.
- Improved Validation process.
- Improved Suppliers Management process.
- Improved Change Management process.
- Improved Design control process.
May 2007 - Jul 2009
2 years 3 monthsTuttlingen, Germany
Project Manager for Product Development
Messrs. Urotech and Aesculap
- Research and Realisation of Development Projects.
- Development of new stone-basket-tiples for the Urology.
- Development of new ureteral stents device.
- Development of a new kind of dilatator for stones extraction.
- Development of a new kind of coat for rigid ureter scopes.
- Development and construction of a Satinsky clamp.
- Conception and Development of a vessel’s clamp for the Electro surgery (vessel welding with pressure and heat from the Current).
- Technical Documentation.
- Submitted patent for new medical device: Patent No. 10 2009 034 251.6 for the stone-basket-Tipless.
- Submitted patent for new medical device: Patent No. 10 2009 022 379.7 for the coat for rigid ureteroscops.
Oct 2001 - Mar 2007
5 years 6 monthsGermany
Research assistant at the Institute of Nuclear Physics
Karlsruhe Research Centre
- Astrophysics and elementary particle physics.
Summary
My name is Dieudonné Mbarga; I have been a professional in the Medical Device Field for 20 years. I am a medical device consultant focusing on Quality, Quality Assurance, and Regulatory Affairs in Europe, North America, and Asia. My Projects involved working on products of classes I-II-III, Combination devices (drug devices), and in Vitro Diagnosis (IVDD/ IVDR). I also support several Notified Bodies in Europe, such as DQS, TUV Nord, and SGS, as Lead Auditor and Technical Documentation reviewer for MDR, MDD, MDSAP, ISO 13485, and ISO 9001.
Languages
French
NativeGerman
AdvancedEnglish
AdvancedEducation
Sep 2011 - Feb 2012
University of Nurnberg
Business Management · Nuremberg, Germany
Sep 2011 - Feb 2012
Zhejiang University of Shanghai
Business Management · Shanghai, China
Jan 2010 - Jun 2011
Plymouth University
Executive Management · London, United Kingdom
...and 1 more
Certifications & licenses
Project Management Professional Certification (PMP)
Quality Management Auditor
Regulatory Affairs Manager International
Quality Management Representative in Industries
Six Sigma Greenbelt
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