Compliance Manager

2 weeks ago

Cavite City, Calabarzon, Philippines HRTX Full time ₱900,000 - ₱1,200,000 per year

Responsibilities:

  • Oversee company-wide adherence to regulatory requirements, including FDA, ISO standards, and other industry regulations.
  • Ensure products, labeling, and manufacturing processes meet FDA requirements and manage official FDA submissions and communications.
  • Lead ISO certification processes and coordinate with teams to integrate ISO standards into daily operations.
  • Maintain and renew all necessary business permits, licenses, and certifications.
  • Conduct risk assessments, develop mitigation strategies, and provide cross-functional compliance training.
  • Manage compliance documentation, ensuring secure storage, organization, and accessibility for audits.
  • Lead, manage, and provide guidance to a team of compliance specialists to ensure efficient execution of tasks.

Qualifications & Skills:

  • Experience of 5-7 years in regulatory compliance, quality assurance, or a similar field, with a focus on FDA and ISO compliance.
  • Bachelor's degree in Regulatory Affairs, Quality Management, Business, or a related field (advanced certifications are a plus).
  • Expertise in FDA regulations, ISO standards, compliance documentation management, and proficiency in compliance software.

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