About the Role
We are hiring for a regional Quality & Regulatory leadership role, supporting APAC (including China) markets within the Medical Device / Life Sciences industry.
This role sits within the commercial organisation and partners closely with global stakeholders across Quality, Regulatory, R&D, and Sales.
Responsibilities
- Act as the regional point of contact for QM/RA matters across APAC
- Drive implementation and continuous improvement of Quality Management Systems (ISO 9001, ISO 13485, ISO/IEC 17025)
- Lead regulatory submissions and compliance activities across multiple APAC markets
- Partner with global and regional teams to ensure alignment of quality processes and standards
- Oversee complaint handling, audits, and field safety actions
- Drive harmonisation and standardisation of quality processes across Sales & Service organisations
- Track and monitor QM/RA KPIs and performance metrics
Requirements
- Minimum 5 years of experience in Quality Management and/or Regulatory Affairs within Medical Device or Life Sciences industry
- Strong knowledge of ISO 9001 and ISO 13485 (ISO 17025 is an added advantage)
- Experience handling regulatory submissions across APAC markets
- Comfortable working in a matrix, regional environment
- Strong stakeholder management and communication skills
- Degree in Engineering, Life Sciences, or related field
