Assistant Manager / Specialist — Regulatory Affairs
Regulatory & ComplianceKey Responsibilities & Technical Competencies
- Compile Technical Master Files and dossier documentation in accordance with European Union Medical Device Regulation (EU MDR 2017/745) and US FDA requirements.
- Prepare Clinical Evaluation Reports (CERs) and maintain Post-Market Surveillance (PMS) regulatory files.
- Implement and maintain Quality Management Systems (QMS) compliant with ISO 13485 standards.
- Review product labeling, packaging compliance, SOP modifications, and internal quality audit documentation.
- Manage product registration files, dossier submissions, and international regulatory license renewals.
Interested in applying for Regulatory Affairs?
Connect directly with our corporate talent acquisition team.