# Regulatory Affairs & Quality Assurance Executive

> CorDx · Singapore, Singapore · Full-time · Posted 2026-06-26

**Workplace:** on_site

## 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.

## Apply

[Apply at CorDx](https://apply.workable.com/cordx/j/AB588DEDC8/apply)

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