Head of Regulatory Affairs, SEA/APAC – NPI Strategy Lead

Abbott Laboratories; Singapore; On-site; SGD 129,000 - 195,000; Full time

Job summary

A global healthcare leader is seeking a Head of Regulatory Affairs for Southeast Asia. This role requires a minimum of 7 years in Regulatory Affairs within Medical Devices, preferably IVDs. You will drive regulatory submission plans and develop strategies for new product introductions across the region. Strong communication skills and project management abilities are essential for the role, ensuring compliance and maintaining company credibility with stakeholders.

Qualifications

• Minimum of 7 years’ experience in Regulatory Affairs in Medical Devices, preferably in IVDs.
• Knowledge of APAC regulatory environment including SaMD and EU IVDR.

Responsibilities

• Drive and support regulatory submission plans for Southeast Asia.
• Lead the execution of innovative regulatory strategies for new product introductions.
• Develop and manage metrics to track KPIs for SEA countries.

Skills

Regulatory Affairs in Medical Devices

Project Management

Cross-functional Collaboration

Communication Skills

Attention to Detail

Education

Bachelor or higher degree in Biomedical/Medical Sciences, Pharmacy, Engineering or Life Sciences

Job description

A global healthcare leader is seeking a Head of Regulatory Affairs for Southeast Asia. This role requires a minimum of 7 years in Regulatory Affairs within Medical Devices, preferably IVDs. You will drive regulatory submission plans and develop strategies for new product introductions across the region. Strong communication skills and project management abilities are essential for the role, ensuring compliance and maintaining company credibility with stakeholders.