RAQA Specialist

A leading organisation seeks RAQA Specialist in Taiwan to ensure compliance with local and global standards, support registrations and maintain quality systems in a thriving environment.

Key responsibilities:

As a Regulatory Affairs and Quality Assurance Specialist, you will play a pivotal role in ensuring regulatory compliance and maintaining quality systems.

• Prepare and submit new product registrations and manage lifecycle activities (changes, renewals, approvals) with Taiwan health authority and external consultants
• Maintain regulatory files and ensure accurate tracking of submission status and compliance documentation
• Support and maintain QMS in compliance with ISO 13485, GDPMD, and internal global quality requirements
• Support preparation for and participation in health authority inspections (GDP/GMP/QMS), ensuring CAPA actions are effectively implemented and closed; regional or international travel (<10%) may be required for training, audits, and compliance meetings
• Manage vigilance reporting, GDP warehouse support activities, regulatory/quality reporting, and maintenance of RAQA systems (e.g., Veeva Vault)

Candidate profile:

Your proven experience in regulatory affairs and quality assurance within medical device environments makes you an ideal candidate for this role.

• 3–5 years of RAQA experience within the medical device industry, including independent regulatory submissions, internal audits, and support for health authority inspections
• Strong knowledge of ISO 13485, Taiwan medical device regulations, Good Distribution Practice, and GDP-relevant warehouse processes such as storage, distribution, temperature control, and traceability
• Bachelor’s degree in a scientific, technical, or related discipline; ISO 13485 Internal Auditor certification and Veeva Vault experience preferred
• Excellent organisational, communication, and documentation skills in English and Mandarin, with proficiency in MS Word, Excel, PowerPoint, and Outlook
• Ability to work independently and collaborate cross-functionally in both Taipei commercial and New Taipei warehouse office environments, with flexibility for office-based and operational QA support needs

About the company:

This global medical device organisation is recognised for its strong commitment to innovation, regulatory excellence, and patient-focused outcomes. What sets it apart is its investment in advanced product technologies, collaborative culture, and continuous professional development, giving employees the opportunity to contribute to meaningful healthcare solutions while growing within a stable, quality-driven, and internationally connected business environment.

Keywords: compliance, regulatory, quality, ISO13485, audits, CAPA, vigilance, GDPMD, Veeva

What's next:

If you are ready to take the next step in your career journey within regulatory affairs and quality assurance—apply today by clicking on the link provided.