Regulatory Affairs Specialist II

ThermoFisher Scientific Regulatory Affairs Specialist II in Singapore, Singapore

Work Schedule: Standard (Mon-Fri)

Environmental Conditions: Office

Job Description: 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:

1. Compile and review technical documentation for product registrations in Southeast Asia (SEA) countries.
2. Review and edit dossiers to meet countries’ requirements, ensuring the accuracy and consistency of information.
3. Support SEA countries’ channel partners in complying strictly with local regulations.
4. Collaborate with internal and external partners to address regulatory obstacles.
5. Respond to questions related to product registration and change notification from regulatory agencies.
6. Keep track of license validity in SEA countries and ensure licenses are renewed in a timely manner.
7. Stay on top of regulatory requirements and developments, monitor and work with internal/external collaborators to ensure seamless product supply.
8. Provide input for regulatory change assessments to determine the impact on registrations.
9. Handle Adverse Events and Field Safety Corrective Action reporting in countries of responsibility.
10. Assist in QMS maintenance and internal/external audits.
11. Support GMP certificate renewals in countries where applicable.

Requirements:

1. Bachelor’s degree or equivalent experience in a relevant field.
2. 2 - 5 years in regulatory affairs roles in medical devices or in-vitro diagnostics industry.
3. Outstanding organizational skills with the ability to manage multiple tasks.
4. Strong communication and interpersonal skills.
5. Ability to adapt and succeed in a fast-paced environment.
6. Dedication to excellence and a high level of integrity.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.