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