Quality & Regulatory Senior Executive

About the role

We are seeking a hands‑on Quality & Regulatory Executive / Assistant Manager to support OPH Health’s rapidly expanding healthcare‑technology business across Singapore and Southeast Asia. The role will drive quality system implementation, regulatory documentation, product registration and licence maintenance for medical devices and digital health solutions.

Key responsibilities

• Implement and maintain quality management systems (ISO 13485, ISO 9001) and related documentation.
• Prepare regulatory submissions, product registrations and licences (HSA, GMP, GDPMDS).
• Manage supplier quality, customer quality tracking and audit preparation.
• Maintain compliance with GDP, GMP and other relevant standards.
• Collaborate with management, suppliers, consultants and cross‑border teams to ensure regulatory readiness.

Required profile

• Detail‑oriented, practical and highly organised.
• Comfortable working in a lean, fast‑growing environment.
• Willingness to grow into a broader quality and regulatory function.

Required skills

• ISO 13485
• ISO 9001
• Good Distribution Practice (GDP)
• Good Distribution Practice for Medical Devices (GDPMDS)
• Good Manufacturing Practice (GMP)
• Health Sciences Authority (HSA) registration processes
• Medical device regulatory documentation