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 7 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