Associate/manager, Regulatory Affairs, Philippines

Carl Zeiss Pty Ltd

Alabang, Philippines
8 years medical device regulatory experience
Philippines fda regulations knowledge
Iso 13485 quality management system expertise
Responsible for leading regulatory strategy, submissions, and approvals for new product registrations across multiple business segments

Job Summary

  • Responsible for leading regulatory strategy, submissions, and approvals for new product registrations across multiple business segments.
  • Act as the Quality Management Representative to lead internal and external audits ensuring effective implementation of the Quality Management System.
  • Oversee post-marketing surveillance activities including adverse event reporting, recalls, and compliance with local Philippine FDA requirements.

Matching Summary

Responsible for leading regulatory strategy, submissions, and approvals for new product registrations across multiple business segments.

Skills & Requirements

Must-have

  • 8 years medical device regulatory experience
  • Philippines FDA regulations knowledge
  • ISO 13485 Quality Management System expertise

Nice-to-have

  • Certified internal auditor for GDPMD
  • Strong strategic thinking skills
  • Excellent negotiation abilities

Key Requirements

  • Degree in Pharmacy, Chemistry, or Biology
  • Minimum 8 years relevant experience
  • Certified internal auditor (preferred)

Work Rights

Not specified

Tailored Resume

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