Location
singapore
Job Type
Full-time
Posted
June 29, 2026
Job Description
Responsibilities
- 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 actio...
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