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In-Vitro Diagnostics Regulatory Specialist

1 week ago

Singapore Thermo Fisher Scientific Full time

About the Opportunity:

We are looking for a talented Regulatory Affairs Specialist to join our team in Singapore. As a key member of our Asia Pacific regulatory affairs team, you will be responsible for ensuring the compliance of our in-vitro diagnostics products with regulatory requirements in Southeast Asia countries.

Key Responsibilities:

  • Compile and review technical documentation for product registrations in Southeast Asia countries.
  • Review and edit dossiers to meet countries' requirements, ensuring accuracy and consistency of information.
  • Support channel partners in complying 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.
  • Maintain license validity in Southeast Asia countries and ensure timely renewal.
  • Stay up-to-date with regulatory requirements and developments, monitoring and working with collaborators to ensure seamless product supply.
  • Provide input for regulatory change assessments to determine impact on registrations.
  • Handle Adverse Events and Field Safety Corrective Action reporting in countries of responsibility.
  • Assist in Quality Management System (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.
  • 5 years of experience in regulatory affairs roles in medical devices or in-vitro diagnostics industry.