Quality and Regulatory Manager, APAC

MICHAEL PAGE INTERNATIONAL PTE LTD; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A leading healthcare innovator in Singapore is searching for a Regulatory Compliance Lead to oversee QMS and ensure compliance with ISO 13485, EU MDR, and FDA regulations. This role involves acting as the QMS Management Representative and requires strong leadership and analytical skills. Ideal candidates will have a Bachelor's degree in a relevant field and experience in the medical device sector. The position offers a dynamic and mission-driven environment with the chance to make a global impact.

Benefits

Opportunity for international exposure

Dynamic mission-driven environment

Qualifications

• Experience in quality and regulatory roles within the medical device industry.
• Expertise in ISO 13485, EU MDR, and FDA regulations.
• Prior experience as Management Representative and/or PRRC highly desirable.

Responsibilities

• Act as QMS Management Representative under ISO 13485.
• Maintain and improve QMS compliance with relevant regulations.
• Lead internal audits and risk management activities.

Skills

Analytical skills

Leadership skills

Communication skills

Stakeholder engagement

Education

Bachelor's degree in science, engineering or regulatory discipline

Job description

• Lead global QMS and regulatory compliance for breakthrough innovation
• Drive impact across worldwide

About Our Client

Our client is a pioneering healthcare innovator dedicated to transforming the future of medical technology. Backed by over a decade of research and significant global investment, they have introduced a first-of-its-kind device that is redefining standards in patient care. With recent regulatory approvals and a strong commercialisation roadmap, this organisation offers an exciting opportunity to be part of a mission-driven team delivering breakthrough solutions to healthcare providers worldwide.

Job Description

• Act as QMS Management Representative under ISO 13485
• Maintain and continuously improve QMS compliance with ISO 13485, EU MDR and FDA
• Lead internal audits, management reviews and risk management activities
• Drive CAPA systems and support root cause analysis
• Monitor and report QMS performance metrics and KPIs
• Ensure document control and change management processes
• Develop and deliver QMS training programs, including onboarding and refreshers
• Serve as Person Responsible for Regulatory Compliance (PRRC) under EU MDR
• Interpret and apply global medical device regulations and standards
• Prepare and submit regulatory dossiers and product registrations globally
• Maintain regulatory intelligence and communicate changes proactively
• Review and approve marketing and promotional materials for compliance
• Oversee complaint evaluation and vigilance reporting for adverse events
• Lead audit and inspection readiness activities and act as primary contact during audits
• Coordinate timely resolution of audit findings and corrective actions
• Participate in supplier audits as needed

The Successful Applicant

• Bachelor's degree in science, engineering, or regulatory discipline or a related field
• Experience in quality and regulatory roles within the medical device industry
• Expertise in ISO 13485, EU MDR, and FDA
• Prior experience as Management Representative and/or PRRC highly desirable
• Strong analytical, leadership and communication skills
• Excellent communication and stakeholder engagement skills

What's on Offer

• Opportunity to lead compliance for a globally impactful healthcare innovation
• Dynamic, mission-driven environment with international exposure

Contact

Vanessa Chan (Lic No: R2197577/ EA no: 18S9099)

Quote job ref

JN-112025-6883914

Phone number

[phone]