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Malt Strategy
Hilal A.HA

Hilal A.

Consultante Affaires Règlementaires (RAQA) en DM

€380/day
Nantes, FR
3-7 years
Regulatory Compliance
Technical Documentation
MDR 2017/745
ISO 13485
Medical Devices

Average response time: 1 hour

About Hilal

Consultante en affaires réglementaires dans le domaine des dispositifs médicaux (DM), j’accompagne les équipes sur la préparation de documents réglementaires et la mise en conformité (MDR, marquage CE).

Rigoureuse et opérationnelle, j’interviens en support pour faire avancer rapidement les projets.
Consulting and Audits

  • French

    Native or bilingual

  • English

    Fluent

Remote only
Primarily works remotely

Experience

  • Indivi
    Clinical operations admin
    CONSULTING AND AUDITS
    January 2026 - Today (5 months)
    Bâle, Switzerland
    • Monitored study data uploads and ensured data completeness through site follow-ups.
    • Coordinated with vendors and internal teams to resolve data issues in a timely manner.
    • Tracked and reported data status using internal tools and dashboards
    ISO 13485 Amazon Web Services Medical Devices Data analysis Mobile application
  • CONMED FRANCE
    Regulatory Affairs and Quality Assurance Associate
    April 2022 - October 2022 (6 months)
    Lyon, France
    Africa EU MDR 2017/745 UK MDR 2002 MDD to MDR transition in medical devices Post Market Surveillance Reports for Morocco, Internal audit, Risk analysis
  • Confidential
    Regulatory Affairs Specialist
    CONSULTING AND AUDITS
    October 2023 - Today (2 years and 8 months)
    Dubaï, United Arab Emirates
    • Advising clients across health and cosmetic industry in gulf market Reviewing technical documentation
    • Supporting conduct of regulatory risk assessment Acted as the key liaison with regulatory authorities addressing queries
    Regulatory Compliance
Check out Hilal's experience

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Education

  • Master 2 Environmental and human toxicology (TEH)
    UFR Sciences Angers
    2022
    Master 2 Environmental and human toxicology (TEH)
  • Bachelor's in biology
    UFR Sciences Angers
    2020
    Bachelor's in biology
Check out Hilal's education

Certifications

  • Certification of Completion to Mini-Course 2017/745
    Easy Medical Device
    2022

Skill set

Post-Market Surveillance & Vigilance
EMEA
CE marking
Project Management
Quality Management

Categories

  • Other