Regulatory Affairs Specialist
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Job Location:
Taipei City - Taiwan
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 Taiwans objectives.
- Oversee lifecycle activities such as renewals notifications and product withdrawals or phaseouts.
- 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 crossfunctional 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/AIn 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
Required Experience:
IC
Key Skills
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
