Medical Regulatory Executive

Key Responsibilities: Product Registration: Manage and oversee product registration processes in compliance with Malaysia’s medical device regulatory requirements. Prepare, review, and submit documentation required for product registration. Liaise with regulatory authorities and other stakeholders to ensure timely approvals. GDPMD Audit & Compliance: Conduct and assist in GDPMD (Good Distribution Practice for Medical Devices) audits and ensure compliance with regulatory standards. Maintain and update quality procedures and processes to align with industry regulations. Work with internal teams to implement corrective actions and ensure continuous compliance. Documentation & Reporting: Maintain accurate records of regulatory activities, including submissions, approvals, and audit findings. Generate reports and presentations for management using Excel, Word, and PowerPoint. Process Improvement: Analyze current regulatory processes and identify areas for improvement. Propose innovative ideas and solutions to enhance regulatory efficiency. Regulatory Knowledge: Stay updated on Malaysia’s medical device regulatory policies and guidelines. Provide guidance and training to internal teams on regulatory requirements. Key Requirements: Minimum 1 year of experience in medical device registration and regulatory processes. Familiarity with GDPMD audit requirements and compliance practices. Proficient in Microsoft Office (Excel, Word, PowerPoint). Strong analytical and problem-solving skills. Excellent written and verbal communication skills. Ability to work independently and collaboratively in a team environment. Knowledge of Malaysia’s medical device regulatory policies and procedures is essential.