Regulatory Affairs & Quality Assurance Specialist
Job Description
The RAQA Specialist prepares, submits, maintains, and obtains approvals for domestic regulatory submissions. The role supports local quality system activities, including participation in internal audits and management review, to ensure compliance with corporate quality policies, global standards, and Taiwan regulatory requirements.
The RAQA Specialist assists in the creation, implementation, and maintenance of local quality procedures aligned with both global and local guidelines. Consistent with corporate values and quality policy, the role requires professional conduct and effective collaboration with internal and external stakeholders, reflecting a trustworthy, credible, and reliable image of CooperVision.
Essential Functions & Accountabilities:
Regulatory Affairs – Product Registration & Licenses
Prepare, compile, and support submissions for new product registrations to Taiwan health authority.
Support registration lifecycle activities, including changes and renewals.
Monitor regulatory submission status through health authority systems and external consultants.
Maintain complete regulatory files and records.
Quality Assurance & QMS
Support and maintain the local QMS in compliance with Medical Device Good Distribution Practice (GDPMD) and internal global requirements.
Conduct internal audits in accordance with ISO 13485 and GDP requirements, including documentation and follow-up activities.
Participate in Management Review activities, including data preparation, discussion, and action item follow-up.
Support complaint handling in accordance with internal procedures and regulations.
Review artworks, labeling, and promotional materials to ensure regulatory compliance.
Support preparation for and participation in health authority inspections (GDP/GMP/QMS), including CAPA follow-up.
Vigilance / Post-Market Surveillance
Prepare and submit reportable adverse event and vigilance reports to health authority within regulatory timelines.
Maintain vigilance records and support trend analysis.
Warehouse / GDP Scope
Support QA activities related to warehouse and distribution operations.
Support deviations, risk assessments, and CAPAs related to GDP operations.
Reporting & Other Responsibilities
Prepare and submit regular/monthly regulatory and quality reports.
Update and maintain Global RAQA databases (Veeva Vault, Agile, etc.).
Support other RAQA-related projects as assigned.
Travel
Less than10% -
Regional or International travels may be required for trainings or audits or meetings.
Work Environment:
Prolonged sitting in front of a computer
Office environment.
Light lifting and bending.
Work in both commercial office in Taipei and warehouse office in New-Taipei will be required based on business operational needs.
Qualifications
Knowledge, Skills and Abilities:
• Knowledge of medical device regulatory and quality requirements (e.g., ISO 13485 standard).
• Familiar with Taiwan medical device regulations and Good Distribution Practice.
• Strong organizational skills and attention to detail.
• Good written and verbal communication skills in English and Mandarin.
• Proficient in MS Word, Excel, PowerPoint, Outlook. Proficiency in Veeva Vault is preferred.
• Ability to work independently on assigned tasks and collaborate cross-functionally.
Experience:
• 3-5 years of experience in medical device Regulatory Affairs and Quality Assurance.
• Experience conducting internal audits is required.
• Experience participating in Management Review is preferred.
• Experience handling regulatory submissions independently is required.
• Experience supporting health authority inspections (GDP, GMP, or QMS) is preferred.
• Warehouse QA or hands-on experience with GDPMD operations is a strong plus. Understand and evaluate
• GDP-relevant warehouse processes, including storage, distribution, temperature control, and traceability.
Education:
• Bachelor’s degree in a scientific, technical, or related discipline.
• ISO 13485 Internal Auditor certification is preferred.