Compliance Manager
5 days ago
Direct message the job poster from HR Primo Management Services
As a Compliance Manager, you are responsible for overseeing the company's adherence to regulatory requirements, including FDA, ISO standards, and other industry regulations. The role involves developing, implementing, and monitoring compliance policies, managing documentation, and ensuring cross-functional collaboration to mitigate compliance risks. This position ensures that all compliance practices are up-to-date, efficient, and meet the necessary legal and regulatory standards. Additionally, the Compliance Manager will lead and manage a team of compliance specialists to ensure efficient execution of compliance tasks.
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 compliance.
Qualifications:
- Experience: 5-7 years in regulatory compliance, quality assurance, or a similar field, with a focus on FDA and ISO compliance.
- Education: Bachelor's degree in Regulatory Affairs, Quality Management, Business, or a related field; advanced certifications in compliance or quality management are a plus.
- Skills: Expertise in FDA regulations, ISO standards, and compliance documentation management; proficiency in compliance software.
- Competencies: Detail-oriented, analytical, highly organized, with excellent communication skills and the ability to manage multiple projects.
Mid-Senior level
Employment typeFull-time
Job functionLegal
IndustriesHuman Resources Services
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