Beschreibung

Results-driven Regulatory Affairs and Quality Assurance Director with 16+ years of progressive leadership in biological pharmaceuticals, medical devices, IVD, and combination products. Extensive experience managing global regulatory submissions across FDA, EU MDR/IVDR, MEA, APAC, LATAM, Russia, Canada, and Turkey. Certified PRRC with demonstrated ability to build QMS from scratch, lead cross-functional teams, and drive product approvals in highly regulated environments. Fluent in 6 languages.

Sprachen

Französisch
Muttersprachlich oder zweisprachig
Englisch
Muttersprachlich oder zweisprachig
Arabisch
Muttersprachlich oder zweisprachig
Türkisch
Verhandlungssicher
Deutsch
Verhandlungssicher
Chinesisch
Verhandlungssicher

Arbeitsortpräferenzen

Vor Ort möglich

Zurich (bis zu 50 km)

Apoqlar
Senior Regulatory Director & Quality Assurance Consultant
PHARMAZEUTISCHE INDUSTRIE
März 2024 - Heute (2 Jahre und 3 Monate)
San Francisco, Vereinigte Staaten
1 – Pharmaceutical RA & Quality GMP AMM (BD)
• • Built and maintained QMS for pharmaceutical operations in compliance with GMP, GDP, and ICH guidelines; authored SOPs and WIs from scratch.
• • Managed and submitted AMM dossiers (Modules 1 , 2 & 3) for international markets including MEA, Africa, and Europe.
• • Authored CMC variations, QOS, and safety updates; performed GMP audits of manufacturing and distribution sites.
• • Led CAPA management, deviation handling, and change control processes; ensured continuous GMP compliance.
• • Managed labelling compliance, packaging updates, and variation submissions aligned with ANSM, EMA, and regional HA deadlines.
• • Drafted distributor contracts (PRA/PVA); performed post-AMM regulatory monitoring and subsidiary quality guidance.
Mission 2 – | IEC 62304 | Cybersecurity (Apoqlar)
• • Created QMS from scratch for a startup developing AI-powered SaMD (Software as a Medical Device); defined quality processes aligned with ISO 13485 and IEC 62304.
• • Led software lifecycle management per IEC 62304; implemented software development and maintenance processes including SOUP management and verification/validation.
• • Developed regulatory strategy for AI/ML-based medical devices per FDA SaMD guidance and EU MDR Annex I requirements.
• • Ensured cybersecurity compliance per FDA cybersecurity guidance and MDCG 2019-16; produced Software Bill of Materials (SBOM).
• • Built risk management documentation per ISO 14971 integrating software failure modes and AI-specific risk controls.
• • Supported CE Mark and FDA 510(k) submissions for software medical devices; coordinated with Notified Bodies and FDA reviewers.
Regulatory Compliance (MDR, IVDR, FDA, MHRA, Health Canada) SaMD Quality Management System (QMS) intelligence artificielle Hybrid Project Management (PMP & Agile)
Align Technology
Director of Quality & Regulatory Affairs
PHARMAZEUTISCHE INDUSTRIE
Juni 2022 - Februar 2024 (1 Jahr und 8 Monate)
Zug, Switzerland
• • Member of the Senior Leadership Team; drove site regulatory strategy and quality direction.
• • Led CE Mark and 510(k) submissions; built GSPR, CER, and Risk Management Plans in full compliance with EU MDR and 21 CFR 820.
• • Managed international MD registrations: EU MDR, Art. 117, 21 CFR 820/4, ISO 13485, Middle East, Japan, Russia, Africa, APAC.
• • Supervised a team of 7 (2 Quality Managers, 1 Quality Engineer, 4 RA Specialists).
• • Oversaw complaint management, internal auditing, supplier control, document control, calibration, and CAPA programs.
• • Drove risk-based product validation and design input/output project management.
Regulatory Compliance (MDR, IVDR, FDA, MHRA, Health Canada) Risk Management Quality Management System (QMS) Atlassian JIRA Lead Auditor
DBV Technologies
Quality Director & Regulatory Affairs – Drug/Device Combination Products
PHARMAZEUTISCHE INDUSTRIE
Januar 2021 - Mai 2022 (1 Jahr und 4 Monate)
Zürich, Switzerland
• • Led regulatory strategy and submissions for new applications in USA, UK, EU, Asia, and MEA.
• • Authored and submitted BLA and EU MAA dossiers (Modules 1 & 3); managed 510(k) and CE Mark submissions for combination products.
• • Built QMS from ground up: SOPs, WIs, and regulatory documentation per EU MDR, 21 CFR 820, ISO 13485, and GMP.
• • Authored clinical trial authorizations, amendments, PIPs, Fast Track and Breakthrough designation applications.
• • Managed CMC dossier publication and variation/safety update approvals.
• • Led a team of 5; maintained active relationships with FDA, MEA, and European Competent Authorities.
Quality Management System (QMS) Regulatory Compliance (MDR, IVDR, FDA, MHRA, Health Canada) intelligence artificielle Lead Auditor Pharmaceuticals