Ensures compliance with global quality standards by developing, implementing, and maintaining Quality Management Systems (QMS). Conducts audits, identifies gaps, and drives continuous improvement initiatives.

Manages product registration, compliance documentation, and regulatory submissions. Ensures adherence to international regulations and keeps the company informed of changing compliance requirements.

Analyzes clinical trial data to support regulatory submissions and compliance efforts. Ensures data integrity and provides insights for decision-making in product development.

Offers tailored strategies for adhering to industry regulations and standards. Supports organizations in navigating audits, certifications, and regulatory approvals.

Focuses on optimizing internal workflows and QMS to enhance operational efficiency. Identifies bottlenecks and implements best practices to improve productivity and compliance.

Ensures that equipment, processes, and systems meet regulatory requirements through validation protocols. Conducts tests and provides reports to support compliance.

Develops and implements risk assessment strategies for product lifecycle management. Identifies potential compliance risks and formulates mitigation plans to ensure adherence to regulations.

Leads cross-functional teams to ensure timely and efficient execution of regulatory projects, including submissions, audits, and compliance initiatives. Manages timelines, budgets, and resources while ensuring alignment with global regulatory standards and organizational goals.

Ensures systems and processes comply with FDA 21 CFR Part 11 requirements for electronic records and signatures. Oversees validation activities, audits digital systems for compliance, and develops policies and procedures to maintain regulatory adherence.