Quality Assurance and Regulatory Affairs Manager

7 days ago

San Fernando, Central Luzon, Philippines Sta International Corporation Full time ₱840,000 per year

About the Role

We are seeking an experienced QA/RA Manager to lead and oversee Quality Assurance and Regulatory Affairs operations in alignment with US factory requirements. The successful candidate will play a key role in ensuring compliance with ISO 13485, FDA, and In Vitro Diagnostic (IVD) regulatory standards while driving continuous improvement across QA/RA functions.

Key Responsibilities

  • Lead and manage QA/RA operations to ensure alignment with US regulatory and factory requirements.
  • Ensure compliance with ISO 13485, FDA, and IVD regulatory standards.
  • Develop, implement, and maintain QA/RA processes, policies, and documentation.
  • Supervise, mentor, and support staff to uphold company and industry quality standards.
  • Coordinate internal and external audits, regulatory inspections, and submissions.
  • Provide training and guidance on quality and compliance requirements to cross-functional teams.

Qualifications & Requirements

  • Bachelor's degree in Life Sciences, Engineering, or a related field.
  • Minimum of 5 years' QA/RA experience in a medical device manufacturing environment.
  • Strong working knowledge of ISO 13485 and IVD regulations.
  • Demonstrated leadership or supervisory experience.
  • Excellent communication, analytical, and problem-solving skills.

Why Join Us?

  • Opportunity to lead a critical function in a growing and compliant-focused organization.
  • Exposure to global regulatory standards and industry best practices.
  • Collaborative and supportive work environment.

Job Type: Full-time

Pay: Php60, Php70,000.00 per month

Work Location: On the road

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