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.