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Regulatory affair manager

Your responsabilities :

  • Ensure communication with Notified Body and Regulatory Authorities as regulatory responsible for medical devices legal manufacturer
  • Ensure registration of legacy devices
  • Coordinate MDR initial audit preparation
  • Participate to MDR submissions, follow up and changes
  • Maintenance of Technical Documentation and DHF
  • Validation of Regulatory related technical documentation documents (IFU, SSCP, Clinical documents, Risk Management, labeling)
  • Support Regulatory team for Rest of World Registrations as Regulatory Representative of legal manufacturer
  • Collect US regulatory assessment for changes and participate to annual reporting
  • Follow up change approvals in countries
  • Participate to Annual updates
  • Release of labeling materials to ensure compliance with country requirements
  • Validation of gap analysis for standard surveillance
  • Provide updated list of approved country for release and distribution
  • Ensure QMS maintenance of regulatory related documents
  • Participate to regular Quality meeting and perform regulatory assessments (Non-conformities, CAPA, Changes, FSCA etc)
  • Provide data for KPI and Management Reviews
  • Active participation for internal and external audits
  • Participate to supplier contract reviews to ensure MDR implementation

Your profile :

  • Master / Engineer’s degree in a biomedical / scientific field
  • Minimum of 5 years’ experience in Regulatory Affairs in Medical Devices Manufacturing company
  • Knowledge of European, American, Australian and Canadian standards, laws and guidelines applicable to medical devices
  • Knowledge of GXP: GMP, GLP, GDP, GCP, GPVP
  • Ability to balance the business/commercial objective with the detail required to define a compliant process
  • Fluency in French and English
  • Good analytical skills, balancing the big picture with attention to detail
  • Accurate, clear and client friendly communication of technical information, whether verbal, written or face to face
  • A team player, able to act on own initiative, with good interpersonal skills
  • Organized approach and able to work to tight deadlines and independently
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