- Professional
- Optionales Büro in Singapore
Maintain and improve the Quality Management System (QMS) in line with ISO 13485, GDPMDS, and other relevant standards.
Ensure compliance with HSA regulations and other international requirements (e.g. EU IVDR, FDA QSR).
Prepare and manage regulatory submissions and product registrations for medical devices and IVD products.
Handle post-market activities, including product renewals, vigilance reporting, and change notifications.
Manage and update quality documents such as SOPs, work instructions, and forms.
Support and participate in internal and external audits, and follow up on corrective and preventive actions (CAPA).
Conduct training for staff on quality and regulatory topics.
Work with suppliers and internal teams to ensure products and processes meet quality and regulatory requirements.
Support continuous improvement of quality processes and compliance systems.
Requirements
Bachelor’s degree in Life Sciences, Biotechnology, Biomedical Engineering, or a related field.
Minimum 2 years of experience in Quality Assurance, Regulatory Affairs, or related roles within the medical device or IVD industry.
Familiarity with ISO 13485, GDPMDS, EU IVDR, FDA QSR, and HSA regulatory frameworks.
Experience in regulatory submissions, product registration, and audit preparation is an advantage.
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