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Quality and Regulatory Manager, APAC

Singapore Permanent Work from Home or Hybrid View Job Description
You will oversee quality systems and regulatory compliance for a fast-growing medical device organisation with international market presence. This role combines strategic leadership with hands-on execution across ISO 13485, EU MDR, and global regulatory frameworks.
  • 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
+65 6643 9742

Job summary

Function
Healthcare
Specialisation
Healthcare
What is your area of specialisation?
Healthcare / Pharmaceutical
Location
Singapore
Contract Type
Permanent
Consultant name
Vanessa Chan (Lic No: R2197577/ EA no: 18S9099)
Consultant contact
+65 6643 9742
Job Reference
JN-112025-6883914
Work from Home
Work from Home or Hybrid

Diversity & Inclusion at Michael Page

We don't just accept difference - we celebrate it. We encourage applicants from all backgrounds to apply for this role and are committed to building inclusive, diverse workplaces where everyone can thrive. If you require any support or reasonable adjustments during the recruitment process, please let us know.