Regulatory Affairs Specialist

Job Description :

Work Schedule

Environmental Conditions

Thermo Fisher Scientific recently announced that it has entered into an agreement to sell its microbiology business to Astorg, a leading pan-European private equity firm with deep expertise in healthcare, focused on a select set of subsectors, including pharmaceutical services and technology, medtech and related services, life science tools and diagnostics.

This decision follows a thoughtful evaluation as part of Thermo Fisher's ongoing business strategy to actively manage and strengthen our portfolio.

We expect the transaction will be completed in the second half of 2026, subject to customary closing conditions and applicable regulatory approvals. Until the transaction is complete, Thermo Fisher will continue to operate the business.

If you join the microbiology business prior to the close of the transaction, your employment is expected to transition to Astorg.

For more information, please review:

A Day in the Life:

• Compile and review technical documentation for product registrations and product changes submissions in the Asia Pacific (APAC) region.
• Review and edit dossier to meet APAC countries requirements, ensuring consistency and accuracy of product information.
• Support APAC countries channel partners in product registration and compliance with local regulations.
• Collaborate with internal and external stakeholders to gather a detailed perspective by leading meetings and overcoming roadblocks in product registrations.
• Manage Adverse Events and Field Safety Corrective Action reporting in countries of responsibility.
• Keep up to date with regulatory requirements and regulatory development in the Asia Pacific region.
• Interpret changes in the regulatory environment with the ability to coach others on general regulatory frameworks and assess the impact of changes.
• Provide input for regulatory change assessments to determine impact on registrations
• Responsible for maintaining SS620 certification.

Keys To Success:

• Excellent communication and good leadership skills
• Innovative problem-solving abilities and good attention to detail
• Good knowledge of regulatory requirements and willingness to continue learning and expanding regulatory expertise
• Good understanding of the company's products, manufacturing processes, and interactions between various departments
• Strong organizational skills and ability to work to deadlines
• Commitment to personal development

Education:

• B.Sc. in Life Sciences and relevant experience

Experience

• 3 - 5 years in Regulatory Affairs roles in the in-vitro diagnostics (IVD) or medical devices industry
• Demonstrated experience in successful product registrations in Asia Pacific countries

Knowledge, Skills, Abilities

• Regulatory Affairs background with knowledge of Asia Pacific countries IVD standards and regulations
• Comprehensive knowledge of regulatory requirements in the Asia Pacific region, particularly Southeast Asia countries, Korea, Taiwan
• Strong understanding of quality management system and experience in supporting or maintaining QMS systems
• Excellent project management and organizational skills
• Strong analytical and problem-solving capabilities
• Superior written and verbal communication skills
• Proven track record of working to deadlines
• Works well in a team environment
• Eager to learn, develop, and progress in Regulatory Affairs