Regulatory Affairs Officer
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Job Description
Job Summary: The FDA Compliance Officer is responsible for ensuring that the company's
products, processes, and practices comply with all applicable regulations established by the
Food and Drug Administration (FDA). The officer will oversee regulatory compliance activities,
assess the risk, and ensure that the company maintains the highest standards of quality and
safety. The role includes preparing for and managing FDA audits, ensuring regulatory
submissions are completed accurately and on time, and working cross-functionally with other
departments to maintain compliance with federal guidelines.
Key Responsibilities:
β’ Develop, implement, and maintain FDA compliance programs for products, processes,
and operations.
β’ Monitor, interpret, and apply FDA regulations, guidance, and standards to ensure the
company remains in compliance.
β’ Review and approve FDA submissions.
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