Freelancer profile translated to English.
Back to original languageAbout Samir
Passionate about medical devices, I've made regulatory compliance the core of my profession: for me, it's a strategic lever to protect patients and secure your industrial performance.
If your challenge is to obtain or maintain your certificates without multiplying back-and-forth with your notified body, that's exactly where I can help.
With over 14 years of experience in orthopedics, ophthalmology, and active medical devices (classes I to III), I have managed complete MDR transitions, notified body transfers, FDA/ANSM inspections without critical findings, and the drafting of numerous CE technical files and 510(k)s.
My added value: I think like an industrialist, I act like an auditor, and I deliver truly auditable technical files. I intervene on your MDR gap analyses, remediation plans, technical files (Annex II/III, STED, 510(k)), ISO 13485/MDSAP upgrades, audit preparation, and clinical deliverables (CER, PMS/PMCF, retrospective studies).
Based in Besançon, I support manufacturers in France, in person or remotely.
French
Native or bilingual
English
Fluent
Can work on-site
Besançon (up to 50km), Dijon (up to 50km), Bordeaux (up to 50km), Lyon (up to 50km), Paris (up to 50km)
Experience
- HTI TECHNOLOGIES
On Malt
AuditorMEDICALMarch 2026 - March 2026Lyon, FranceConducted an internal QMS audit at HTI Technologie according to ISO 13485 and 21 CFR Part 820, assessing the compliance and effectiveness of quality processes.Analyzed key quality system activities, identified gaps, and formulated concrete improvement areas to strengthen compliance and regulatory control. - FreelanceQA/RA Expert - ISO 13485 AuditorCONSULTING AND AUDITSSeptember 2025 - Today (11 months)Besançon, FranceMedical SectorSenior QA/RA Consultant with over 14 years of experience in medical devices (orthopedics, ophthalmology, active medical devices).Today, I support manufacturers as a freelance Senior QA/RA Consultant and external ISO 13485 auditor to secure their projects, audits, and compliance.I have successfully managed complete MDR transitions (2017/745), drafted Annex II/III technical files, and obtained certificates for complex product portfolios.I am proficient in accessing the EU and US markets (MDR, 21 CFR 820, 510(k) files) as well as managing relationships with authorities and notified bodies (GMED, TÜV, DQS MED, ANSM, FDA).I have participated in the construction and maintenance of ISO 13485 quality management systems and in numerous audits (ISO 13485 / MDR / MDSAP) and inspections (ANSM/FDA).I participated in notified body transfers.In clinical affairs, I supervised the drafting of relevant clinical evidence CEP/CER (ISO 14155, MEDDEV 2.7/1 rev.4), participated in post-market activities PMS/PMCF with the aim of submitting technical files within the deadlines to obtain CE marking for the concerned medical devices.Experienced manager, I have supervised up to 10 employees, managed budgets > €1M, and sat on the Management Committee.Accustomed to demanding, multicultural, and multi-site environments, I know how to translate regulatory requirements into operational roadmaps for R&D, production, and marketing.
- FCI.SAS (A ZEISS COMPANY)Head of Regulatory & Clinical AffairsMEDICALSeptember 2021 - August 2025 (3 years and 11 months)Besançon, FranceSector: Medical Devices – Ophthalmology (classes I to IIb implants)Position: Head of Regulatory & Clinical AffairsManagement & Governance
- Member of the Site Committee of FCI SAS (Besançon)
- Supervision of up to 10 permanent employees (2 hierarchical levels)
- Management of annual budgets > €1M
Key Achievements- Management of the MDR transition with 100% of the portfolio certified,
- Rationalization of 70 MDD files into 53 MDR technical files
- Management of the Notified Body transfer (GMED → DQS MED) while maintaining a permanent state of audit readiness, transfer completed on time
- Single point of contact for authorities and NB, participation in 4 QMS audits with 100% of departmental CAPAs closed on time
- Supervision of the launch of 3 retrospective clinical studies, strengthening PMS/PMCF and CER alignment with clinical and regulatory strategy
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Education
- Master's – Biomaterials & Medical DevicesUniversity of Bordeaux2011Master's – Biomaterials
- Bachelor's – Science & Technology of HealthUniversity of Bordeaux2009Bachelor's – Science & Technology of Health
Certifications
- CQI & IRCA Certified Medical Devices – QMS Auditor/Lead Auditor Training (ISO 13485:2016) (PR369) – Passed (12–16 Jan 2026)BSI