Regulatory Affairs Associate

il y a 3 heures

Lyon, Auvergne-Rhône-Alpes, France Resourcing Life-Science Temps plein

Responsibilities

  • Conduct regulatory impact assessments for product changes, including determination of letter-to-file versus submission requirements.
  • Manage annual registrations, license renewals, and ongoing regulatory notifications.
  • Support the preparation, submission, and maintenance of FDA dossiers and related technical documentation.
  • Coordinate the collection, review, and consolidation of data for international regulatory registrations.
  • Collaborate with global Regulatory Affairs partners and cross-functional stakeholders to ensure timely, compliant submissions.
  • Execute administrative, documentation, and procedural activities supporting the Regulatory Affairs function.

Qualifications

  • Bachelor degree
  • Min 4 years of experience in Regulatory Affairs in the medical device
  • Proven experience with global submissions, preferably including FDA,
  • Excellent communication and problem-solving skills.
  • Fluent in English (written and spoken).

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