Job Description

Roles:

• Overall responsible for leading the Quality System for Business Globally.
• Managing all aspects of Regulatory and Quality Strategy Development, Implementation and Communicating directly with Global Regulatory Agencies on all regulatory matters.

Responsibilities:

• Serve as the key contract for regulatory agency, notified body and customer audits of the facilities.
• Develop and Implement efficient and effective regulatory strategies to bring products to market (Domestic & International)
• Development and Implement strategies for educating the FDA on various aspects of the technology and scientific principles upon which the product system operations.
• Maintain excellent relationships with regulatory agencies and subcontractors.
• Prepare and Submit marketing approval applications, Product Certifications, Design Dossiers, International Licenses, etc.
• Identify relevant quality standards for product development, manufacturing and defining design requirement for domestic and international markets.
• Ensure the company is in full compliance with regulatory agencies.
• Promote the development of a facility wide understanding of the key elements related to quality system and regulatory compliance requirements.
• Effectively lead and manage department regulatory and quality personnel.
• As a member of the senior management team, provide sound advice and guidance regarding the impact of regulatory and quality issues on overall corporate strategy and operations.
• Determining the root cause of problems that involves compliance with FDA requirements.
• Overseeing the corrective and preventive actions for the problems.
• Conducting Recall.
• Handling preparation and follow up for FDA/ Regulatory inspections.
• Keep a regulatory watch and inform the departments concerned of any regulatory changes.
• Prepare, review and approve external and Internal reports and others documentation required by regulatory agencies.
• Identify ways to continuously improve quality and compliance with regulations and company standards, policies and procedures.