Regional RA/QA Leader — Global Impact, Flexible Work Arrangements

KARL STORZ SE & Co. KG; Singapore; On-site; SGD 120,000 - 170,000; Full time

Benefits offered by this job

Transport allowance

Public transport access

Flexible work arrangements

Group health insurance

Flexi-benefit reimbursement

Wellness programs

Professional development

Global exposure & travel

Job summary

KARL STORZ SE & Co. KG in Singapore seeks a Regulatory Affairs/QA leader to drive product registrations, renewals, and regulatory changes across SEA.

You will anticipate shifts and advise leadership on market access, representing SEA & Taiwan in regional RA strategy discussions. Responsibilities include ensuring ASEAN regulatory compliance (HSA, GDPMDS) and international standards (FDA QSR, EU MDR, ISO 13485), owning SOP lifecycle management, and supervising post‑market surveillance and audits.

Qualifications

• More than 5 years RA/QA experience in medical diagnostic equipment, pharmaceutical, medical device distribution or manufacturing environment.
• Proven track record leading audits and driving regulatory approvals.
• Deep expertise in ASEAN regulatory frameworks (HSA, GDPMDS) and familiarity with international standards (FDA QSR, EU MDR, ISO 13485, GMP).

Responsibilities

• Lead product registration, renewals, and regulatory change management across SEAT and represent SEA & Taiwan in regional RA strategy discussions.
• Ensure full compliance with ASEAN regulations and international standards; own SOP lifecycle management and policy alignment with global standards.
• Drive continuous improvement in quality systems and post-market surveillance and act as Management Representative for certification bodies/regulators.
• Build strong distributor relationships to achieve regulatory timelines and enforce compliance standards.
• Train new employees on SOPs and local compliance regulations; supervise RA/QA team performance across region.

Skills

Leadership

Stakeholder management

Audit management

Regulatory approvals

Regulatory affairs knowledge

Quality systems knowledge

Education

Bachelor's degree in a recognized university

Job description

KARL STORZ SE & Co. KG in Singapore seeks a Regulatory Affairs/QA leader to drive product registrations, renewals, and regulatory changes across SEA.

You will anticipate shifts and advise leadership on market access, representing SEA & Taiwan in regional RA strategy discussions. Responsibilities include ensuring ASEAN regulatory compliance (HSA, GDPMDS) and international standards (FDA QSR, EU MDR, ISO 13485), owning SOP lifecycle management, and supervising post‑market surveillance and audits.