Regulatory Affairs Specialist II

Work Schedule

Environmental Conditions

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.