Job Description
1. 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).
2. Assist in ensuring compliance with applicable regulatory requirements and standards across all markets.
3. Support post-market regulatory activities, including product renewals, vigilance reporting, and change notifications.
4. Assist in maintaining and improving the Quality Management System (QMS) in accordance with ISO 13485, GDPMDS, and other applicable standards.
5. Ensure quality processes and documentation are aligned with regulatory requirements.
6. Prepare, review, and maintain quality and regulatory documentation, including SOPs, work instructions, and records.
7. Support internal and external audits (e.g. regulatory inspections, certification audits), including audit preparation and follow-up on corrective and preventive actions (CAPA).
8. Coordinate with cross-functional teams (e.g. R&D, Operations, Supply Chain) and suppliers to ensure compliance with regulatory and quality requirements.
9. Provide support on regulatory and quality matters to internal stakeholders when required.
10. Assist in conducting training on regulatory and quality topics.
11. Support continuous improvement initiatives for QMS and regulatory compliance processes.
Job Requirements
1. Bachelor’s degree in Life Sciences, Biotechnology, Biomedical Engineering, or a related field.
2. At least 2 years of relevant experience in Regulatory Affairs and/or Quality Assurance within the medical device or IVD industry.
3. Basic knowledge of HSA regulations, ISO 13485, GDPMDS, and familiarity with EU IVDR and FDA QSR.
4. Exposure to regulatory submissions and product registration is an advantage.
5. Understanding of QMS processes, documentation control, and CAPA is preferred.
6. Good organizational, communication, and coordination skills.
