Regulatory Affairs Assistant

KeyResponsibilities

• Prepare, compile, and coordinate the submissionof regulatory dossiers for medical device registrations in compliance withapplicable regulatory requirements.
• Coordinate with regulatory authorities andinternal and external stakeholders to facilitate regulatory activities, supportproduct registrations, and address regulatory queries.
• Monitor regulatory submissions and maintainregulatory status records to ensure timely approvals and compliance withregulatory timelines.
• Monitor regulatory developments and communicaterelevant updates on local and international medical device regulations tointernal stakeholders.
• Maintain and organize regulatory documentation,but not limited to certificates, registration approval/licenses.
• Support regulatory compliance activities,including document reviews, labelling compliance, and other regulatory-relatedmatters.
• Perform other duties and responsibilities asassigned from time to time.

Required Qualifications

• Bachelor’s degree / Diploma in Life Sciences,Pharmacy, or related field
• Minimum 6 months to 1 year of relevant workingexperience, preferably in the medical device, pharmaceutical, or life sciencesindustry.
• Familiarity with medical device regulations andquality management requirements, including ASEAN Medical Device Directive(AMDD), regional regulations in Southeast and South Asia, Australia TGArequirements, EU MDR, US FDA regulations, and ISO standards (e.g., ISO 13485).
• Knowledge of or experience in Regulatory Affairsand/or Quality Assurance within the medical device industry is an advantage.
• Proficient in written and spoken English, witheffective communication and interpersonal skills.
• Proficient in Microsoft Office applications(e.g., Word, Excel, PowerPoint, and Outlook).