Urgent! QMS & Regulatory Manager Job Opening In Singapore, Singapore – Now Hiring Maternal Newborn Health Innovations
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.
This is an individual contributor role reporting to the Chief Regulatory and Quality Officer.
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.
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Unlock Your QMS Regulatory Potential: Insight & Career Growth Guide
Real-time QMS Regulatory Jobs Trends in Singapore, Singapore (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for QMS Regulatory in Singapore, Singapore using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 628 jobs in Singapore and 580 jobs in Singapore. This comprehensive analysis highlights market share and opportunities for professionals in QMS Regulatory roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! Maternal Newborn Health Innovations is currently hiring and seeking a QMS & Regulatory Manager to join their team. Feel free to download the job details.
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An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Maternal Newborn Health Innovations adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a QMS & Regulatory Manager Jobs Singapore varies, but the pay scale is rated "Standard" in Singapore. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for QMS & Regulatory Manager typically include Operations Specialties Managers and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the Maternal Newborn Health Innovations's products or services and be prepared to discuss how you can contribute to their success.
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