About the role
JOB DESCRIPTION:
Main Responsibilities:
- Prepare, submit, and obtain approvals for medical device registrations and other regulatory permits for assigned products in Taiwan, while supporting post-approval regulatory activities and ongoing compliance requirements.
- Coordinate with Corporate Regulatory Affairs, Subject Matter Experts (SMEs), regulatory agencies, and internal cross-functional stakeholders to support regulatory submissions, compliance activities, and business objectives.
- Maintain accurate, organized, and audit-ready regulatory documentation, quality records, registration plans, and related materials using company systems and tools (e.g., WindChill)
- Evaluate product changes and applicable regulatory requirements throughout the product life cycle and support the implementation of necessary actions to ensure continued regulatory compliance.
- Complete all assigned training and provide regulatory, administrative and operational support to the direct supervisor and Regulatory Affairs team in accordance with company policies, procedures, and quality system requirements.
Other Functions and Responsibilities:
- Perform administrative tasks related to the department as required by the line manager.
- Perform additional tasks assigned by the line manager when required.
- Execute job responsibilities in accordance with applicable Standard Operating Procedures (SOPs) under Global Regulatory Services.
Skills & Experience Required:*
1. Bachelor’s degree or higher required, preferably in Life Sciences, Pharmacy, or a related field.
2. Good interpersonal and communication skills.
3. Sufficient English communication skills, including reading, writing, listening, and speaking, to perform job responsibilities effectively.
4. Adaptable to complex work environments and tasks
5. Familiar with the use of Microsoft Office
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:
MD Medical Devices
LOCATION:
Taiwan > Taipei : Mingsheng Commercial Building
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Skills & Tags
Aplyr's read
Abbott Laboratories is a leader in healthcare innovation, attracting professionals dedicated to advancing medical technology and patient care on a global scale.
What's promising
- •Abbott's diverse product range offers stability and growth opportunities.
- •Strong global presence enhances career mobility and international experience.
- •Commitment to R&D fosters a culture of innovation and learning.
What to watch
- •Regulatory challenges can impact product launch timelines.
- •High competition in the healthcare sector pressures market share.
- •Complex organizational structure may slow decision-making processes.
Why Abbott
- •Abbott's focus on both diagnostics and nutrition sets it apart from typical pharmaceutical companies.
- •Extensive global footprint provides unique cross-border project opportunities.
- •Abbott's investment in emerging markets offers growth in diverse regions.
Aplyr’s read is generated by AI from public sources. Was it useful?
About Abbott
Abbott Laboratories is a global healthcare company that develops and manufactures a wide range of medical devices, diagnostics, nutrition products, and branded generic pharmaceuticals.
