Job Description

• Support regulatory activities, including preparation and submission of product registrations for medical devices and IVDs to HSA and other regulatory authorities (e.g. EU IVDR, FDA).

• Assist in ensuring compliance with applicable regulatory requirements and standards across all markets.
• Support post-market regulatory activities, including product renewals, vigilance reporting, and change notifications.
• Assist in maintaining and improving the Quality Management System (QMS) in accordance with ISO 13485, GDPMDS, and other applicable standards.
• Ensure quality processes and documentation are aligned with regulatory requirements.
• Prepare, review, and maintain quality and regulatory documentation, including SOPs, work instructions, and records.
• Support internal and external audits (e.g. regulatory inspections, certification audits), including audit preparation and follow-up on corrective and preventive actions (CAPA).
• Coordinate with cross-functional teams (e.g. R&D, Operations, Supply Chain) and suppliers to ensure compliance with regulatory and quality requirements.
• Provide support on regulatory and quality matters to internal stakeholders when required.
• Assist in conducting training on regulatory and quality topics.
• Support continuous improvement initiatives for QMS and regulatory compliance processes.

Requirements

• Bachelor’s degree in Life Sciences, Biotechnology, Biomedical Engineering, or a related field.
• At least 2 years of relevant experience in Regulatory Affairs and/or Quality Assurance within the medical device or IVD industry.
• Basic knowledge of HSA regulations, ISO 13485, GDPMDS, and familiarity with EU IVDR and FDA QSR.
• Exposure to regulatory submissions and product registration is an advantage.
• Understanding of QMS processes, documentation control, and CAPA is preferred.
• Good organizational, communication, and coordination skills.