Regulatory Affairs Executive

Responsibilities: - Handle medical device product registrations, renewals, and change notifications with the Medical Device Authority (MDA). - Apply for, maintain, and renew the company's Establishment Licence and other regulatory approvals. - Prepare and submit regulatory applications and follow up closely on authority queries through to approval. - Develop, review, and maintain Quality Manuals, SOPs, forms and related quality documentation. - Ensure the Quality Management System (QMS) is effectively implemented, maintained, and continuously improved in compliance with GDPMD requirements. - Coordinate and monitor QMS activities, including document control, corrective and preventive actions (CAPA), and continuous improvement initiatives. - Liaise with external parties on regulatory and quality-related matters. - Support internal and external audits, inspections, and certification activities and ensure timely follow-up on audit findings. - Work closely with internal departments to ensure compliance with regulatory, quality, and company requirements. - Promote awareness of regulatory and quality requirements throughout the organisation. - Maintain accurate regulatory records, licences, registrations and quality documentation. Requirements: - Degree in Life Sciences, Biology, Chemistry, Biomedical Science or related field. - Experience in Regulatory Affairs, GDPMD or the medical device industry will have an added advantage. - Good knowledge of MDA regulations, GDPMD requirements and medical device registration processes is preferred. - Proficient in Microsoft Office applications (Word, Excel, and PowerPoint). - Proficient in English and Bahasa Malaysia (written and spoken). - Responsible, detail-oriented, organised and able to manage multiple tasks effectively. - Positive attitude with good interpersonal and teamwork skills.