Quality Management System and Regulatory Manager - D14 Geylang, Eunos, SG

Roles & Responsibilities

We are partnering with a emerging US-based medical equipment manufacturer focusing on innovations that reduce preventable harm and improve health outcomes for maternal and newborn health issues. As part of their expansion, they are looking to hire the following position for their Singapore team.

Quality Management System and Regulatory Manager

Position Overview :

This role oversees QMS and regulatory compliance, serving as ISO 13485 Management Representative and EU MDR PRRC. Responsibilities include ensuring compliance with global regulations, managing audits, submissions, complaints, training, and cross-functional support across the product lifecycle.

Key Responsibilities :

Quality Management System (QMS)

• Serve as the QMS Management Representative as required by ISO 13485.
• Maintain and continuously improve the QMS to ensure ongoing compliance with ISO 13485, EU MDR and FDA 21 CFR Part 820.
• Lead internal audits, management reviews, and risk management activities.
• Drive corrective and preventive action (CAPA) systems and support root cause analysis efforts.
• Monitor and report on QMS performance metrics and key quality indicators (KPIs).
• Ensure proper document control and change management processes are implemented.
• Develop, coordinate and conduct QMS training programs, including onboarding and regular refresher sessions, to ensure employee’s understanding and compliance with quality procedures and regulatory requirements.

Regulatory Affairs & Compliance

Complaint Handling & Vigilance Reporting

Audit & Inspection Readiness

Education & Experience Requirements :

Skills Requirements :

EA Personnel Registration No : R1106329

EA License No : 12C6254

Tell employers what skills you have

CAPA

FDA

Regulatory Compliance

Quality Management

Change Management

Ability To Work Independently

Regulatory Affairs

ISO

Root Cause Analysis

Risk Management

Compliance

Attention to Detail

Audits

Vigilance

Regulatory Requirements

Audit