- 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
