We are seeking a skilled Regulatory Affairs & Compliance Officer to manage product registrations, ensure compliance with international regulatory requirements, and oversee ISO and MDR audit processes. This role requires a deep understanding of global medical device regulations and quality management systems.

Key Responsibilities:

• Prepare, compile, and submit regulatory dossiers for product registrations, renewals, and variations.
• Ensure compliance with local and international regulations
• Plan, coordinate, and participate in ISO 13485 and EU MDR audits, including preparation of documentation and corrective actions.
• Liaise with regulatory authorities, notified bodies, and testing laboratories to facilitate approvals and certifications.
• Maintain regulatory documentation and audit records.
• Provide regulatory and compliance guidance to internal teams during product development, manufacturing, and market launch.