Quality Assurance and Regulatory Affairs Manager

2 days ago

Cavite City, Calabarzon, Philippines John Clements Japan Desk (PERSOL PHILIPPINES) Full time ₱1,200,000 - ₱1,800,000 per year

JOB DESCRIPTION

  • Lead and oversee Quality Assurance (QA) and Regulatory Affairs (RA) operations aligned with US factory requirements.
  • Ensure compliance with ISO 13485, FDA, and In Vitro Diagnostic (IVD) regulatory standards.
  • Develop, implement, and maintain QA/RA processes, policies, and documentation.
  • Supervise and mentor staff, ensuring adherence to company and industry quality standards.
  • Coordinate audits, inspections, and regulatory submissions.
  • Provide training and guidance on quality and compliance requirements.

JOB QUALIFICATIONS

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

Job Types: Full-time, Permanent

Pay: Php50, Php70,000.00 per month

Benefits:

  • Opportunities for promotion
  • Promotion to permanent employee

Application Question(s):

  • Willing to work on night shift (9:00 PM – 6:00 AM) or shifting schedule?

Work Location: In person

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