Regional RA/QA Leader: ASEAN Compliance & Quality

KARL STORZ; Singapore; On-site; SGD 120,000 - 180,000; Full time

Benefits offered by this job

Leave benefits

Birthday benefits

Transport allowance

Public transport access

Flexible work arrangements

Group health insurance

Job summary

KARL STORZ is seeking a senior Regulatory Affairs and Quality Compliance leader in Singapore to drive product registrations, renewals, and regulatory change management across SEAT. You will ensure ASEAN and global standard compliance, own SOP lifecycle management, and lead audits with regulatory authorities.

The role requires deep knowledge of HSA, GDPMDS, FDA QSR, EU MDR, ISO 13485, and proven capability to manage cross-functional teams, risk-based controls, and post-market surveillance

Qualifications

• Bachelor's degree required; RA/QA experience in medical devices or pharma preferred.
• Proven track record leading audits, regulatory approvals and compliance programs.
• Strong understanding of ASEAN regulatory frameworks (HSA, GDPMDS) and international standards.

Responsibilities

• Lead product registration, renewals, and regulatory change management across SEAT regions.
• Ensure compliance with ASEAN and international standards; own SOP lifecycle management.
• Drive quality governance, risk-based controls, and post-market surveillance across functions.
• Manage internal & external audits and interaction with regulatory bodies.
• Train and mentor RA/QA teams; coordinate cross-functional initiatives.

Skills

Leadership

Stakeholder management

Regulatory affairs

Quality assurance

Audits

Communication

Education

Bachelor's degree

Tools

Documentation control system

Job description

KARL STORZ is seeking a senior Regulatory Affairs and Quality Compliance leader in Singapore to drive product registrations, renewals, and regulatory change management across SEAT. You will ensure ASEAN and global standard compliance, own SOP lifecycle management, and lead audits with regulatory authorities.

The role requires deep knowledge of HSA, GDPMDS, FDA QSR, EU MDR, ISO 13485, and proven capability to manage cross-functional teams, risk-based controls, and post-market surveillance