Compliance Manager

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.