QMS & Regulatory Manager

The Quality Management System (QMS) and Regulatory Manager is responsible for the operational leadership and oversight of the organization’s QMS and regulatory compliance functions. This individual serves as the QMS Management Representative in accordance with ISO 13485 and as the Person Responsible for Regulatory Compliance (PRRC) under the EU Medical Device Regulation (MDR).

This role entails ensuring robust compliance with ISO 13485, EU MDR, and 21 CFR Part 820, including the implementation and enforcement of QMS processes, preparation and submission of global regulatory dossiers, and evaluation of complaints for adverse event reporting. The manager also reviews marketing materials for regulatory alignment, leads readiness activities for external audits and inspections, delivers regular QMS training and refreshers, and works cross-functionally to ensure regulatory and quality support throughout the product lifecycle.

DUTIES AND 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.

• Interpret and apply global medical device regulations and standards.

• 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

• Perform other duties as assigned

EDUCATION AND WORK EXPERIENCE

• 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

• 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.

• Fluent in English and Mandarin is a must. Proficiency in other languages (e.g., French, Italian, Spanish) is a plus.