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Regulatory Affairs Specialist II

Location Singapore, 新加坡 Job Id R-01305938 Job Type 全职 Category 质量与注册 Remote 混合办公
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JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Unique Opportunity

Thermo Fisher Scientific Inc. seeks a Regulatory Affairs Specialist II in Singapore to join the Asia Pacific regulatory affairs (RA) team for the in-vitro diagnostics product range for sale in Asia Pacific markets.  This role offers a chance to play a part in regulatory processes and compliance, ensuring product quality and safety.

Responsibilities

  • Compile and review technical documentation for product registrations in Southeast Asia (SEA) countries.

  • Review and edit dossiers to meet countries’ requirements, ensuring the accuracy and consistency of information.

  • Support SEA countries’ channel partners in complying strictly with local regulations.

  • Collaborate with internal and external partners to address regulatory obstacles.

  • Respond to questions related to product registration and change notification from regulatory agencies.

  • Keep track of license validity in SEA countries and ensure licenses are renewed in a timely manner.

  • Stay on top of regulatory requirements and developments, monitor and work with internal/external collaborators to ensure seamless product supply.

  • Provide input for regulatory change assessments to determine the impact on registrations.

  • Handle Adverse Events and Field Safety Corrective Action reporting in countries of responsibility.

  • Assist in QMS maintenance and internal/external audits.

  • Support GMP certificate renewals in countries where applicable.

Requirements

  • Bachelor’s degree or equivalent experience in a relevant field.

  • 2 - 5 years in regulatory affairs roles in medical devices or in-vitro diagnostics industry.

  • Outstanding organizational skills with the ability to manage multiple tasks.

  • Strong communication and interpersonal skills.

  • Ability to adapt and succeed in a fast-paced environment.

  • Dedication to excellence and a high level of integrity.

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