About Sylia
Pharmacist (PharmD) – Regulatory & Clinical Affairs Expert
Regulatory Affairs expert in medical devices and pharmaceutical products, with strong expertise in the preparation, authoring, and submission of technical documentation for CE marking under MDR (EU) 2017/745, as well as in ensuring global regulatory compliance (EU, FDA, Canada, China, Japan).
Proven experience in complex projects involving Class IIb, Class III, and Class III combined medical devices incorporating medicinal substances.
Extensive experience in clinical activities, including clinical strategy development and management of clinical evaluation documentation (CER, PMCF), particularly for high-risk and combination devices.
Extensive experience in managing CTD dossiers for combined products as well as DMF dossiers.
Recognized for scientific rigor, strong regulatory expertise, and the ability to support efficient and compliant market access.
French
Native or bilingual
English
Fluent
Spanish
Basic
Arabic
Native or bilingual
Can work on-site
Annecy (up to 50km), Genève (up to 10km), Lyon (up to 10km), Lausanne (up to 10km)
Experience
- AraymondlifeRegulatory Affairs Consultant – Medical Devices and Primary Packaging for Injectable DrugsPHARMACEUTICALS INDUSTRYFebruary 2025 - Today (1 year and 4 months)Voreppe, France- Led regulatory strategy for primary packaging of injectable drugs and medical devices under EU,US, Canadian, Chinese, and Japanese regulations and Pharmacopeias.- Regulatory and Standards watch- Management and submission of DMFs (Drug Master File) in CTD format in the US, Canada, and China.
- PRODIMEDRegulatory Affairs and Clinical Consultant -Gynecological product (class III)/combined devicesPHARMACEUTICALS INDUSTRYApril 2023 - February 2025 (1 year and 10 months)- Writing and updating CE marking technical files for the transition from 93/42/EEC directive to EU regulation 2017/745.- Project lead for the writing of the regulatory dossier on drug substance with an ancillary action in class III medical devices (CTD Format).- Answering the notified body’s questions.- Clinical Project lead (Identification of clinical strategy, clinical file review: CER, CEP and PMCF).- Regulatory watch and gap analysis
- Laboratoires VivacyRegulatory Affairs Specialist – Aesthetic products & Medical Devices (class III)PHARMACEUTICALS INDUSTRYOctober 2022 - March 2023 (5 months)Archamps, France- Writing and updating of CE marking technical files according to 93/42/CEE directive and EU 2017/745regulation.- Change control : Assessment of regulatory impact.- Lead of risk management activities.- Review and validation of clinical evaluation and biocompatibility documents.
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Education
- Master 2 Medical Devices from Design to MarketUniversité de Montpellier2020Medical Device Regulation
- Master 2 Development of Health Products: Human Drugs and Medical DevicesUniversity of Limoges2019
Skill set
Categories
- Other