Freelancer profile translated to English.
Back to original languageAbout Albert
Specialized consultant for over ten years in medical device software regulation, software quality assurance, and embedded systems engineering, I support companies in the compliance and development of their digital products with high regulatory requirements.
I have led numerous compliance projects for medical device software (#SaMD, #SiMD), managed software development, and defined Verification & Validation strategies adapted to agile environments.
Thanks to strong technical skills, a high level of commitment, great autonomy, and a pronounced sense of initiative, I put my efficiency at the service of your projects to help you achieve your quality and regulatory objectives.
I can assist you with the following topics, among others:
- Compliance of medical device software (standalone or embedded) according to #MDR 2017/745, particularly standard IEC 62304
- Deployment of a QMS adapted for standalone medical software (SaMD)
- Management of software development in an agile environment
- Management of software/system requirements and V&V planning
- Validation of Computerized Systems (#VSI)
Do not hesitate to contact me to discuss your project and explore the most suitable solutions for your needs.
French
Native or bilingual
English
Fluent
Can work on-site
Paris (up to 50km)
Experience
- EnsweetQARA and R&D ConsultantMEDICALJuly 2025 - Today (11 months)Lille, FranceEnsweet, a telemedicine startup developing telerehabilitation solutions for patients with chronic conditions.As R&D and QARA Consultant, my role is to structure quality processes for QMS audits and to capitalize on development data in Jira to produce the technical documentation for the DHF to be included in the technical file submitted in December 2025.Responsibilities:
- Conduct a GAP analysis and define remediation actions
- Draft and approve quality system reference documents (procedures, instructions, plans, etc.)
- Restructure requirements, risk, and test management under Jira
- Implement cybersecurity requirements for medical devices
- Review and revise risk analysis (Safety, Usability, and Cybersecurity) and its deliverables
- Construct the Design History File (DHF): Design inputs, specifications, software architecture, Verification and Validation protocols, test reports, traceability matrix, Design Review, Release Note
- Ensure compliance of Design Change activities
- Manage NC, CAPA, change control
- Prepare and participate in the BSI QMS audit for ISO 13485 certificate renewal
- Compile and update technical files (initial submission, deliverables, and responses to Notified Body rounds)
- Support clinical evaluation activities
- GUERBETSupport for Computerized System ValidationPHARMACEUTICALS INDUSTRYFebruary 2025 - June 2025 (4 months)Aulnay-sous-Bois, FranceTo commission a new production and packaging line for a medication, my mission was to propose and implement a validation remediation strategy for all computerized systems on the line:- Identify the CS to be validated: Filler, EMS, Interlocking, CCIT - Labeler, CTA, etc.- Develop a status report to establish the history of qualification activities previously carried out- Develop a Quality Position Paper- Propose a qualification and validation strategy for the CS equipment- Develop a qualification and validation plan- Update user specification documents #URS- Develop a risk analysis for each piece of equipment- Propose a QI/QO protocol for each computerized system- Execute protocols and write QI/QO/QP reports- Rule on the validation of each CS
- IpsenPhamaLead QARA for SaMD compliance with MDRMEDICALDecember 2024 - April 2025 (4 months)Boulogne-Billancourt, FranceIpsen Pharme is a brand of the Ipsen group, a leader in the manufacture of various pharmaceutical products.As QARA manager, my role was to coordinate all stakeholders involved in the development and compliance of SaMD. I notably structured the implementation of the eQMS under Confluence, drafted procedures and instructions, particularly for Design & Development, Post-Market Surveillance, and Vigilance. Ensured process adherence – Implementation of CAPAs.Responsibilities:• Improve requirements, risk, and test management under Jira• Ensure software traceability• Improve the structure of the entire quality management system under Confluence• Produce several SOPs and QMS Instructions• Ensure proper execution of device vigilance responsibilities and post-market surveillance aspects• Ensure the implementation of audit CAPAs.• In coordination with the PO and IT quality assurance, ensure process adherence for SaMD and MDR compliance. Implement and monitor corrective actions if necessary.• Continue the evolution of the QMS to allow SaMD expansion outside the EU.• Support discussions with the legal manufacturer.
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Education
- Bachelor of TechnologyUniversité des Montagnes2012Bachelor's degree, Biomedical technology
- Bachelor of Engineering in Biomedical EngineeringISIFC2016Master's degree, Biomedical Engineering
Certifications
- ISTQB FoundationISTQB2024