About Tiana
Consultante senior en affaires réglementaires et qualité (QARA) avec plus de 15 ans d’expérience internationale dans l’industrie des dispositifs médicaux, en environnement startup innovante, ETI et multinationales.
J’interviens sur des projets complexes en conformité réglementaire, stratégie de marquage CE, documentation technique et mise en place/amélioration de Systèmes Qualité (ISO 13485, FDA QSR).
Je vous accompagne sur l’ensemble du cycle de vie produit : conception, validation, enregistrements internationaux, audits, PMS/PMCF.
J’ai travaillé sur l’ensemble des classes de dispositifs médicaux (I, IIa, IIb, III), y compris les dispositifs implantables, les logiciels médicaux (SaMD) et les produits combinés.
Mon approche est structurée, opérationnelle et adaptée aux contextes exigeants, en forte croissance ou en phase de mise en conformité critique.
French
Native or bilingual
English
Fluent
Can work on-site
Paris (up to 50km)
Experience
- AT PARTNERFREELANCE QUALITY & REGULATORY AFFAIRS CONSULTANTPHARMACEUTICALS INDUSTRYJanuary 2022 - Today (4 years and 5 months)France• Transition Management – Medical devices & Combination Products• Leading regulatory strategy and roadmap definition for global compliance• Lead RA on Design & Development projects to ensure compliance with applicable regulations (EU MDR, 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304)• Supervision of technical documentation (DHF, DMR, Design Inputs/Outputs, Risk Files)• Supporting MDSAP, ISO 13485 and MDR audits and inspections• Liaison with Notified Bodies and Competent Authorities• Creating and revising regulatory and quality procedures• Managing non-conformities, CAPAs, and complaints
- DPO - CHRONOLIFEQUALITY & REGULATORY AFFAIRS DIRECTORJanuary 2018 - January 2022 (4 years)Paris, France• Appointed Person Responsible for Regulatory Compliance (PRRC)• Appointed Data Privacy Officer (DPO)• Full implementation of QMS under ISO 13485 and 21 CFR Part 820 (Chronolife and subcontractors)• MDR 2017/745 and GDPR 2016/679 deployment• Oversight of Class I, IIa, IIb product development projects• Regulatory lead for Design & Development projects, ensuring compliance with design control requirements and applicable standards (ISO 13485, ISO 14971, IEC 62304)• Led risk management process and usability documentation
- BRACCO INJENEERINGREGULATORY AFFAIRS MANAGERJanuary 2017 - January 2018 (1 year)Lausanne, VD, Switzerland• Regulatory lead on Medical Devices & Combination Products (Classes I, Is, IIa, IIb)• Managed global product lifecycle (design changes, post-market activities)• Led regulatory activities on Design & Development projects for new and legacy combination products• Supported worldwide registrations : US (510(k)), EU (CE marking), China, Brazil, Japan• Maintained regulatory documentation (Technical Files, Clinical Evaluation Reports, Risk Files)• Implemented post-market surveillance and vigilance processes per MDR• Ensured global compliance with 21 CFR Part 820, EU MDD/MDR, and ISO 13485
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Education
- ENGINEERING DEGREE IN BIOTECHNOLOGY SUPBIOTECHSupBiotech2011ENGINEERING DEGREE IN BIOTECHNOLOGY SUPBIOTECH
- MASTER'S DEGREE IN HEALTH ECONOMICS, LAWS & POLICYUniversité Paris Descartes2012MASTER'S DEGREE IN HEALTH ECONOMICS, LAWS & POLICY
Skill set
Categories
- Other