Quality Management System and Regulatory Manager

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**
- Serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR for full or selected scope of responsibility.
- Lead the preparation and submission of regulatory dossiers and product registrations (e.g., CE Mark Technical Documentation, Asia, Middle East, etc.).
- Maintain regulatory intelligence and proactively communicate changes to the organization.
- Collaborate with marketing and commercial teams to ensure labelling, instructions for use (IFU), and advertisements meet internal regulatory and quality requirements.
- Review and approve global marketing and promotional materials to ensure consistency with approved product claims and compliance with regional regulatory requirements (e.g., EU MDR, FDA advertising and promotional guidelines and other global standards).

**Complaint Handling & Vigilance Reporting**
- Oversee complaint evaluation and determine whether complaints meet criteria for reportable adverse events/incidents (e.g., EU vigilance).
- Ensure timely reporting to regulatory authorities and maintain appropriate documentation and tracking.

**Audit & Inspection Readiness**
- Lead the preparation and coordination for external audits by regulatory authorities (e.g. Notified Body audits, regulator inspections).
- Serve as the primary contact during audits and ensure timely resolution of findings and implementation of corrective actions.
- Maintain audit readiness at all times through ongoing training, internal audits, and QMS review.
- Participate in supplier audit, as needed

**Education & Experience Requirements**:

- Bachelor’s degree in science, engineering, or regulatory-related discipline
- Minimum 8-10 years of experience in quality and regulatory roles in the medical device industry.
- Strong knowledge and hands-on experience in implementing and enforcing compliance with ISO 13485, EU MDR and 21 CFR Part 820 across all stages of the product lifecycle. Familiar with ISO 14971.
- Proven ability to manage regulatory compliance activities and QMS in dynamic environment.
- Start-up or scale-up experience within a legal manufacturer setting is highly advantageous, especially in establishing or maturing QMS and regulatory frameworks.
- Demonstrated experience preparing and submitting global regulatory dossiers and managing interactions with regulatory authorities.
- Prior experience in Management Representative and/or PRRC role is highly desirable.

**Skills Requirements**:

- In-depth knowledge of international regulatory requirements and QMS standards.
- Strong analytical and decision-making skills, particularly for complaint evaluation and regulatory reporting.
- Excellent written and verbal communication skills.
- Self-motivated and proactive leader with a demonstrated ability to work independently and drive cross-functional collaboration across diverse teams.
- Ability to work effectively across different time zones and accommodate night calls when required to support global teams, partners, or regulatory engagements.
- High attention to detail, integrity, and ethical conduct.

EA Personnel Registration No: R1106329

EA License No: 12C6254