Compliance Manager
2 hours ago
Job Summary:
As a Compliance Manager, you will be responsible for ensuring the company's full compliance with regulatory requirements, including those set by the FDA, ISO, and other relevant industry authorities. Your role includes developing, implementing, and maintaining compliance policies, managing documentation, and fostering collaboration across departments to minimize compliance risks. You will lead and supervise a team of compliance specialists to ensure that all compliance activities are executed effectively. This position guarantees that the company's compliance systems remain current, efficient, and fully aligned with legal and regulatory standards.
KEY RESPONSIBILITIES:
- Regulatory Compliance Management
Oversee company-wide compliance with FDA, ISO, and other relevant regulations, ensuring adherence across all departments.
- FDA and Industry-Specific Compliance
Ensure products, labeling, and manufacturing processes meet FDA requirements; manage FDA submissions and communications.
- ISO Standards and Quality Assurance
Lead ISO certification processes and coordinate with teams to integrate ISO standards into operations.
- Permit and License Management
Maintain and renew all necessary business permits, licenses, and certifications.
- Risk Assessment and Issue Management
Conduct risk assessments, develop mitigation strategies, and provide compliance training.
- Documentation and Record Keeping
Manage compliance documentation, ensuring secure storage, organization, and accessibility for audits.
- Cross-Functional Collaboration
Collaborate with R&D, manufacturing, and legal teams to align on compliance initiatives and communicate with regulatory agencies.
- Continuous Improvement and Regulatory Intelligence
Monitor regulatory changes and propose improvements to compliance strategies, processes, and training.
- Training & Development
Support career development for the team through seminars, trainings, and collaboration with HR.
- Team Management
Lead, manage, and provide guidance to a team of compliance specialists, ensuring efficient execution of compliance tasks and fostering a culture of continuous improvement.
QUALIFICATIONS
- 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 in compliance or quality management are a plus.
- Expertise in FDA regulations, ISO standards, and compliance documentation management; proficiency in compliance software.
- Detail-oriented, analytical, highly organized, with excellent communication skills and the ability to manage multiple projects.
Job Type: Full-time
Pay: Php48, Php50,000.00 per month
Benefits:
- Company events
- Discounted lunch
- Free parking
- On-site parking
Work Location: In person
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