Head of Regulatory and Quality, APAC

Singapore Permanent Work from Home or Hybrid View Job Description
The client is looking for a seasoned Regulatory and Quality leader to provide strategic oversight for regulatory affairs and quality system across APAC. This role combines leadership, compliance expertise and cross-functional collaboration to enable business growth and regulatory excellence.
  • Lead Regulatory and Quality strategy across diverse APAC markets
  • Drive compliance and innovation in a global medical device organization

About Our Client

Our client is a global medical technology innovator committed to delivering breakthrough solutions that improve patient outcomes and redefine healthcare standards. With a strong presence in over multiple countries, they offer a dynamic environment where strategic thinking and operational excellence drive meaningful impact.

Job Description

  • Lead quality and regulatory compliance activities across the APAC region
  • Develop and implement quality systems and processes in alignment with industry standards
  • Ensure compliance with regional regulatory requirements for life science products
  • Collaborate with cross-functional teams to support product launches and market access
  • Conduct audits and inspections to maintain quality and regulatory compliance
  • Provide guidance and training to internal teams on regulatory requirements and quality standards
  • Monitor changes in regulatory policies and update internal processes accordingly
  • Act as a key liaison with regulatory authorities and external stakeholders in the APAC region. Serve as a member of APAC Leadership and Global teams
  • Oversee product registrations and lifecycle maintenance in APAC
  • Develop and maintain regulatory systems aligned with global QMS
  • Lead interactions with Health Authorities and manage compliance processes
  • Build and mentor in-country Regulatory and Quality teams to strengthen regional capability
  • Manage relationships with distributors and license holders for compliance
  • Develop APAC regulatory strategies to support business growth
  • Ensure audit readiness and lead regulatory due diligence
  • Stay current with regional and international regulations and standards
  • Manage budget and provide leadership to teams

The Successful Applicant

  • Bachelor's degree in a scientific or technical discipline
  • Experience in medical device Regulatory and Quality roles
  • Proven leadership experience with regional or global scope
  • Strong knowledge of APAC regulatory requirements and QMS standards
  • Familiarity with FDA and EU CE marking processes is an advantage
  • Excellent communication, problem-solving and stakeholder management skills

What's on Offer

  • Strategic leadership role with regional impact
  • Opportunity to shape Regulatory and Quality practices in a global Medical Device organisation
  • Competitive remuneration and career development prospects
Contact
Vanessa Chan (Lic No: R2197577/ EA no: 18S9099)
Quote job ref
JN-122025-6911241
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-122025-6911241
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.