Dieudonné Mbarga
PRRC, Quality and Regulatory Representative
Experience
Feb 2021 - Present
4 years 6 months Singapore
PRRC, Quality and Regulatory Representative
Biofourmis AG
- Manage a portfolio of assigned projects
- Provide quality and regulatory guidance in product development projects
- Lead the R&D team in writing MDR/FDA technical documentation
- Perform inspections and audits
- Ensure QMS and technical documentation comply with standards and regulations such as ISO 13485 (QMS), EU/2017/746 (IVDR), and 21 CFR Part 820
- Monitor regulatory updates and keep the QMS aligned with current requirements
- Write clinical evaluation plans and reports
Feb 2021 - Present
4 years 6 months Switzerland
Consultant Auditor
SGS Switzerland
- Conduct ISO 13485 & ISO 9001 certification audits
- Perform MDD surveillance audits
Dec 2020 - Jan 2021
2 months Sweden
RA/QA Specialist
ImmunoIVD
- Plan technical documentation updates for the transition from IVDD to IVDR
- Update technical documentation and prepare files for notified body review
- Lead the team for IVDR CE conformity assessment readiness
- Provide product development guidance to the R&D team
Jun 2020 - Jan 2021
8 months Oslo, Norway
RA/QA Specialist
NEC Oncommunity AS
- Plan QMS updates for the transition from IVDD to IVDR
- Perform gap assessments on QMS and technical documentation against IVDR
- Remediate CE technical documentation and develop FDA approval strategy
- Update IVDD technical documentation to meet IVDR requirements
- Establish an ISO 13485 Quality Management System and improve procedures
- Guide product development for the R&D team
May 2020 - Dec 2020
8 months Switzerland
Quality Assurance Specialist
Novartis Pharma
- Manage assigned projects and provide functional expertise for medical devices and combination products
- Offer quality and regulatory guidance in combination device development
- Write, review, and approve deliverables (procedures, records, third-party work, clinical trial materials, components) for GMP compliance
- Support medical device risk management with proactive tools and approaches to minimize impact on supplies and patients
- Release medical devices for clinical studies and commercial use
- Perform inspections and audits
Apr 2020 - Present
5 years 4 months Germany
Consultant Auditor
TÜV NORD CERT GmbH
- Conduct ISO 13485 and MDR certification audits
- Perform MDD surveillance and MDSAP audits
- Carry out CE-MDR conformity assessment audits
- Review technical files
Sep 2019 - Jul 2020
11 months Bonaduz, Switzerland
Regulatory Affairs Specialist
Hamilton Medical AG
- Provide regulatory support for R&D product development to ensure compliance in target markets worldwide
- Prepare and submit technical documentation to regulatory authorities for market authorization
- Develop regulatory strategies to guide submission pathways, considering requirements (testing, clinical data), product claims, and country priorities
- Write the Product Security Risk Management procedure
- Conduct product security risk management activities and documentation for connected devices
- Lead product safety risk management activities and documentation
- Write the product biological safety evaluation
- Draft and support the clinical evaluation report
- Support usability activities and compile the Usability Engineering File
- Review design and development documentation and guide the R&D team
Aug 2019 - Present
6 years Germany
Consultant Auditor
DQS Notified Body
- Perform ISO 13485 certification audits
- Conduct MDD surveillance and MDSAP audits
- Carry out CE-MDR conformity assessment audits
Dec 2018 - Jun 2019
7 months Unterschleißheim, Germany
Quality Assurance Specialist (R&D, QA/RA)
Philips/TomTec
- Write the Usability Engineering procedure and templates compliant with IEC 62366-1:2015 Chapter 5 & Annex C
- Create Usability Engineering files for product DHF
- Update DHF documentation per ISO 13485:2016, MDR, QSR, MDSAP, and country regulations
- Draft regulatory documentation for product certification
- Improve and perform risk management per ISO 14971
- Identify gaps in processes/instructions, especially development under IEC 62304, and plan and implement changes
- Prepare for and monitor audits
- Handle complaints and CAPAs
- Manage suppliers (ISO/IEC 17025 – test equipment, calibration)
Feb 2018 - Dec 2019
11 months Kornwestheim, Germany
Products Risk Manager (R&D, QA/RA, Manufacturing Project)
Roche Invitro Diagnostics
- Lead and coordinate risk management activities across departments
- Write DFMEA for new product development
- Advise the team on risk management, regulatory, and quality engineering best practices
- Maintain risk documents within the quality management system
- Ensure all risk activities and documentation comply with relevant regulations
- Remediate noncompliance issues in risk files and update documents as needed
- Train employees on the risk management process per ISO 14971
Jul 2017 - Jan 2018
7 months Au, Switzerland
Quality Assurance Specialist (R&D, QA, RA Project)
Lyca Microsystems
- Provide quality and regulatory guidance for R&D projects
- Drive the team to complete R&D documentation through all phases
- Remediate DHF files and improve product portfolio documentation
- Support GMP and corporate audits
- Optimize QMS (product development procedure, engineering change, risk management, verification and validation)
- Write the Usability Engineering File per IEC 62366
- Conduct design reviews for R&D projects
- Manage R&D department CAPAs
Dec 2016 - Jun 2017
7 months Aalen, Germany
Quality Assurance Specialist (R&D Project)
Carl Zeiss
- Act as QA manager for R&D projects
- Guide the team through R&D documentation phases
- Lead writing of project technical documentation (PRS, SRS, HWRS, SWRS, etc.)
- Set strategy to achieve CE marking and 510(k)
- Review product technical documentation
- Draft risk management documents (DFMEA, risk analysis, PFMEA, all risk reports)
- Write quality documents for the project
Jan 2015 - Dec 2016
1 year Freiburg im Breisgau, Germany
Project Manager for UDI (Unique Device Identification)
Stryker
- Lead the UDI/Direct Part Marking (DPM) project
- Develop the project strategy plan and documentation
- Review product technical documentation (drawings, DHF, etc.)
- Update risk management documents
- Manage change requests for implementing DPM on navigation products
- Work with R&D, manufacturing, QA, and RA to approve DPM documentation
- Update DHF and technical documentation for certificates
Jan 2015 - Sep 2015
9 months Eindhoven, Netherlands
Quality Assurance Manager
Philips
- Lead quality for development projects
- Draft regulatory requirements for the project
- Write supplier quality contracts for new products (supplier approval)
- Collaborate with clinical teams to set clinical strategy for 510(k)
- Drive the team to complete technical documentation
- Lead R&D milestone tasks
- Create project structure, assign tasks and responsibilities
- Analyze DHF failures and develop solutions with the team
- Write regulatory documentation for certification
- Update technical documentation for certificates in Asia and Latin America
- Perform risk management (DFMEA, user FMEA) for R&D projects
- Resolve CAPAs and NCRs on existing products
Jun 2014 - Mar 2015
10 months Berlin, Germany
Project Manager DHF Remediation
Leoni AG
- Set up project structure, assign tasks and responsibilities
- Draft regulatory requirements for the project
- Analyze DHF failures and develop solutions with the team
- Work with departments to plan and implement resolutions for failures
- Initiate and implement solutions through CAPAs
Mar 2014 - Jun 2014
4 months Zuidland, Netherlands
Quality Management System Expert
D.O.R.C.
- Assess the QMS regarding validation processes
- Improve the quality manual for validation
- Write SOPs, work instructions, and forms for validation
- Assess the risk management process and set improvement requirements
- Train employees on new procedures
May 2013 - Jun 2014
1 year 2 months Zuchwil, Switzerland
GRQP Subject Matter Expert (Project Leader)
Johnson&Johnson
- Improve processes (risk management, calibration, inspection, test and release, etc.)
- Write SOPs and work instructions
- Update the risk management file
- Update manufacturing processes
- Write legacy review (audit) reports and remediation plans to resolve deviations and noncompliance
Feb 2012 - Jun 2013
1 year 5 months Beringen, Switzerland
Project Lead Manufacturing Engineer
Abbott Vascular Ltd
- Implement R&D projects in production
- Provide technical support to production teams throughout the project
- Optimize processes and production
- Develop products with R&D collaboration
- Perform risk management (risk analysis, PFMEA)
- Qualify and validate production facilities
- Train production staff
- Prepare audits and present production issues
- Control production documentation
- Validate computer systems
- Lead balloon blow process optimization (Six Sigma to improve balloon yield)
- Lead CAPA on pinhole issue (team of 5): initiation, investigation, implementation
- Lead CAPA on extrusion validation (team of 6): initiation, investigation, implementation
- Lead extrusion equipment qualification (team of 2, 22 machines): IQ, OQ
- Lead extrusion tubing process validation (team of 6): develop strategy and plan, write process FMEA, participate in risk analysis, write OQ/PQ plans, execute runs, write reports
Jun 2010 - Dec 2011
1 year 7 months Plochingen, Germany
Quality Assurance Engineer
Ceramtec GmbH
- Administer document management system
- Update document management software
- Revise and correct quality documents
- Conduct internal and supplier audits
- Qualify and manage suppliers (including ISO/IEC 17025 for test equipment and calibration)
- Test and inspect per AQL ISO 2859-1 and ISO 16269-1
- Write SOPs, work instructions, and forms
- Lead QM system optimization projects (ISO 13485, 21 CFR 820, 21 CFR 11)
- Improve document control, internal audit, CAPA, quality control, risk management, validation, supplier management, change management, and design control processes
May 2007 - Jul 2009
2 years 3 months Tuttlingen, Germany
Project Manager for Product Development
Messrs. Urotech and Aesculap
- Research and execute development projects
- Develop new stone-basket tips for urology
- Develop new ureteral stent devices
- Create a new dilator for stone extraction
- Develop a new coating for rigid ureteroscopes
- Design and build a Satinsky clamp
- Conceptualize and develop a vessel clamp for electrosurgery (welding with pressure and heat)
- Prepare technical documentation
- File patents for new medical devices: stone-basket tipless (Patent No. 10 2009 034 251.6) and ureteroscope coating (Patent No. 10 2009 022 379.7)
Oct 2001 - Mar 2007
5 years 6 months Germany
Research assistant at the Institute of Nuclear Physics
Karlsruhe Research Centre
- Conducted research in astrophysics and elementary particle physics
Summary
My name is Dieudonné Mbarga; I have been working in the medical device field for 20 years. I am a consultant focused on Quality, Quality Assurance, and Regulatory Affairs in Europe, North America, and Asia. My projects include products in classes I, II, and III, combination devices (drug-device), and in vitro diagnostics (IVDD/IVDR). I also support several notified bodies in Europe, such as DQS, TUV Nord, and SGS, as a Lead Auditor and technical documentation reviewer for MDR, MDD, MDSAP, ISO 13485, and ISO 9001.
Languages
French
Native
English
Advanced
German
Advanced
Education
Sep 2011 - Feb 2012
University of Nurnberg
Business Management · Nuremberg, Germany
Sep 2011 - Feb 2012
Zhejiang University of Shanghai
Business Management · Shanghai, China
Jan 2009 - Jun 2011
Plymouth University
Executive Management · London, United Kingdom
Certifications & licenses
Project Management Professional (PMP)
Quality Management Auditor
Regulatory Affairs Manager International
Quality Management Representative in Industry
Six Sigma Green Belt
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