We are seeking an experienced Regulatory Affairs professional with expertise in Clinical Evaluation Reports (CER), literature review, risk management, and Quality Management Systems for medical devices. The incumbent will be responsible for supporting global regulatory compliance activities, technical documentation preparation, and ensuring adherence to applicable regulatory standards and requirements.
Key Responsibilities
- Prepare, review, and maintain Clinical Evaluation Reports (CERs) for Class IIb and Class III medical devices in accordance with applicable regulatory requirements.
- Perform risk management activities in accordance with ISO 14971, including risk analysis, risk assessment, risk control, and benefit-risk evaluation.
- Support preparation and maintenance of technical documentation, design dossiers, and regulatory submissions.
- Ensure compliance with Quality Management System (QMS) requirements i...