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.
- 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.
- 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.
Pour postuler pour ce job, envoyer vos informations par mail à firstname.lastname@example.org