APAC Regulatory Affairs Leader

SOLVENTUM; Singapore; Hybrid; SGD 180,000 - 240,000; Full time

Job summary

Solventum is seeking a Regulatory Affairs Leader for Asia to shape regulatory strategies across medical devices in the APAC region. This role leads a regional regulatory team, partners with R&D, QA, Clinical Affairs, and senior leadership to drive market access and faster product approvals.

The position requires a Master’s and at least 10 years in Regulatory Affairs for medical devices, strong English communication, and proven global team leadership.

Qualifications

• Bachelor’s degree in science or engineering required.
• 10+ years of regulatory affairs in the medical device industry.
• Master’s degree in a science or engineering field preferred.
• Experience leading global teams across APAC.
• Excellent English verbal and written communication.

Responsibilities

• Develop and execute regulatory strategies to achieve product approvals in Asia.
• Direct complex regulatory decisions among stakeholders and senior leaders.
• Advise on regulatory strategy, health authority interactions, and submissions.
• Collaborate with R&D, QA, and Clinical Affairs to integrate requirements.
• Represent regulatory affairs in leadership forums for key portfolios.
• Mentor regulatory staff and teams across product modalities.
• Establish team goals aligned with regional strategy.

Skills

Regulatory leadership

Regulatory affairs experience

English communication

Global team leadership

APAC regulatory knowledge

Education

Master’s degree in science or engineering

Bachelor’s degree or higher in Science or Engineering

Job description

Solventum is seeking a Regulatory Affairs Leader for Asia to shape regulatory strategies across medical devices in the APAC region. This role leads a regional regulatory team, partners with R&D, QA, Clinical Affairs, and senior leadership to drive market access and faster product approvals.

The position requires a Master’s and at least 10 years in Regulatory Affairs for medical devices, strong English communication, and proven global team leadership.