Regional Quality & Regulatory Lead 

About the job

Morgan Philips Group has partnered with a global leader in Life Sciences dedicated to providing high-precision solutions for research and clinical diagnostics. We are seeking a high-caliber Regional Quality & Regulatory Lead to serve as the primary authority for Quality Management and Regulatory Affairs across the APAC region. You will be responsible for harmonizing quality systems across Sales and Service organizations, ensuring rigorous regulatory compliance. 

What You'll Do (Key Responsibilities)

• Architect Regional Quality Strategy: Lead the implementation, harmonization, and continuous improvement of Commercial Quality Management Systems (ISO 9001, ISO 13485, ISO/IEC 17025) across APAC to reduce complexity and maximize operational efficiency.

• Regulatory & Compliance Leadership: Act as the leading regional authority for product registrations and submissions. You will oversee adverse event reporting, Field Safety Corrective Actions (FSCA), and maintain total audit readiness for interactions with notified bodies and health authorities.

• Operational Excellence & Monitoring: Develop and roll out sophisticated QM, PMS, and RA KPIs. You will oversee the CRM complaint process, ensuring data integrity and proactive risk mitigation across the Sales and Service network.

• Strategic Stakeholder Partnership: Serve as the critical interface between Corporate QM/RA, R&D, and regional business leaders. You will align local market requirements with global strategic goals while providing functional guidance to regional teams.

• Drive Cultural Transformation: Act as a role model to initiate a transformation in the QM/RA mindset, focusing on prevention, customer satisfaction, and continuous improvement through mentorship and cross-functional leadership.

What You'll Bring (Requirements)

• Education: A University degree in Medical Sciences; a Master’s or Business-related education is an advantage.

• Experience: Minimum 5+ years of progressive Quality Management experience within the Life Science or Medical Device industry, with deep expertise in ISO 17025 and ISO 13485. 

• Regulatory Expertise: Proven track record in managing Regulatory Affairs and complex submissions specifically within the APAC region.

• Soft Skills: Exceptional intercultural competence with experience navigating Asian and Western organizational structures. You must possess strong project management skills and the ability to communicate effectively in English and Mandarin. 

What's Next

If this sounds interesting, please apply soonest and we will reach out. Morgan Philips is compliant to PDPA laws, and all applications are strictly confidential. Do note that once your profile is submitted to Morgan Philips, we may be in touch for other potential positions which fit you.