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Malt Strategy
Sylia BouriahSB

Sylia Bouriah

Regulatory Affairs Expert Medical Devices

€700/day
Annecy, FR
8-15 years
CE marking
MDR 2017/745
Directive 93/42/CEE
Clinical Strategy
GMP

Average response time: 1 hour

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

  • Araymondlife
    Regulatory Affairs Consultant – Medical Devices and Primary Packaging for Injectable Drugs
    PHARMACEUTICALS INDUSTRY
    February 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.
  • PRODIMED
    Regulatory Affairs and Clinical Consultant -Gynecological product (class III)/combined devices
    PHARMACEUTICALS INDUSTRY
    April 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 Vivacy
    Regulatory Affairs Specialist – Aesthetic products & Medical Devices (class III)
    PHARMACEUTICALS INDUSTRY
    October 2022 - March 2023 (5 months)
    Archamps, France
    - Writing and updating of CE marking technical files according to 93/42/CEE directive and EU 2017/745
    regulation.

    - Change control : Assessment of regulatory impact.

    - Lead of risk management activities.

    - Review and validation of clinical evaluation and biocompatibility documents.
Check out Sylia's experience

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Education

  • Master 2 Medical Devices from Design to Market
    Université de Montpellier
    2020
    Medical Device Regulation
  • Master 2 Development of Health Products: Human Drugs and Medical Devices
    University of Limoges
    2019
Check out Sylia's education

Skill set

Regulatory Affairs
Medical Devices

Categories

  • Other