Regulatoy Affairs Specialist


Our client, an innovative MedTech company, is currently looking for a Regulatoy Affairs Specialist.

In this position, the candidate must be experienced within CE Mark submission and FDA regulatory submission and with quick availability.

Responsabilities :

  • Develop Regulatory Affairs strategies,
  • Lead CE mark submission and ensure documentation requirements related to design, risk analysis, Verification & Validation, testing and traceability,
  • Preparing the country-specific RA registration files for national and international registrations of medical devices,
  • Work in close cooperation with internal (product development, product management, management) and external stakeholders,
  • Active participation during Notified Body Audits or FDA Inspections,
  • Ensure compliance with relevant norms and regulations,
  • Establish and maintain appropriate documents and records in compliance with the Client’s QMS,
  • Actively following the development/emergence of the new regulatory requirements and assessing potential impact for existing product or product development,
  • Contribute to establishing best practices.

Profile :

  • Master degree in Life Science,
  • Several years (5+ years) of experience in international Regulatory Affairs with medical Devices classIIB matters,
  • Ability to assess business risks and handle regulatory assignments,
  • Indeep knowledge of standard 60601-1 Medical electrical equipment and ISO14971 :2012 Risk Management tools,
  • Knowledge of ISO 13485,
  • Excellent communication skills in English and French, both verbal and written,
  • Entrepreunarial spirit and ability to think and act startegically.

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