Freelancer profile translated to English.
Back to original languageAbout Tiana
Senior Consultant in Regulatory Affairs and Quality (QARA)with over 15 years of international experience in themedical deviceindustry, ininnovative startup, mid-sized, and multinationalenvironments.
I work on complex projects inregulatory compliance, CE marking strategy, technical documentation, and implementation/improvement of Quality Systems (ISO 13485, FDA QSR).
I support you throughout the entire product lifecycle:design, validation, international registrations, audits, PMS/PMCF.
I have worked on all classes of medical devices (**I, IIa, IIb, III**), includingimplantable devices, medical software (SaMD), and combination products.
My approach is structured, operational, and adapted to demanding contexts, high growth, or critical compliance phases.
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