Regulatory Affairs Specialist

     

JOB DESCRIPTION:

Main Responsibilities:

• Responsible for managing new and variation registrations, securing approvals at the earliest possible time, and effectively allocating resources to support the achievement of Abbott Diagnostics Taiwan’s objectives.  
• Oversee lifecycle activities such as renewals, notifications, and product withdrawals or phase‑outs.
• Review labeling, product information, and promotional materials to ensure regulatory accuracy and adherence to local requirements.  
• Identify and assess regulatory risks related to submissions, product claims, supply constraints, and market changes, and propose mitigation strategies. Provide the strategy to internal teams and collaborate with cross‑functional stakeholders to ensure stable product supply.

Skills & Experience Required:

• Minimum 2 years MD/IVD industry experience regulatory affairs relevant.
• Good cross-functional communication and coordination skills.
• Local study execution and clinical evaluation experience for Class III IVDs is a plus.
• Proven project management skills.
• Commitment to building and sustaining visibility and engagement across APAC and global teams.

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

CRLB Core Lab

        

LOCATION:

Taiwan > Taipei Hsien : Building H2

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable