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Regulatory Affairs & Quality Assurance Specialist at CooperCompanies

Taipei, , Taiwan -

Full Time

Start Date

Immediate

Expiry Date

12 Jul, 26

Salary

0.0

Posted On

13 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Quality Assurance, ISO 13485, Medical Device Regulations, Good Distribution Practice, Internal Audits, Management Review, Regulatory Submissions, GDP, GMP, QMS, Warehouse QA, GDPMD, MS Office, Veeva Vault, Cross-functional Collaboration

Industry

Medical Equipment Manufacturing

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.

Responsibilities

The RAQA Specialist is responsible for preparing and maintaining domestic regulatory submissions while ensuring compliance with corporate quality policies and global standards. The role also involves participating in internal audits, management reviews, and the implementation of local quality procedures.