Vice President of Regulatory Affairs

Position Statement

Executive Management

• Serve as a key and active member of senior management teams, interacting to ensure business objectives are aligned and that the company is performing to operational objectives.
• Coach and mentor the Quality and Regulatory organizations ensuring appropriate levels of accountability for decision making and clearly communicate cross-functionally within the organization.

Quality

• Responsible for company’s product quality and reliability to meet or exceed regulatory.
• Responsible for company’s Quality Compliance to ensure compliance with regulatory agencies and all applicable standards.
• Develop and execute quality design and quality assurance strategy for new product development and sustaining business activities.
• In support of the quality system, provide effective leadership support, training and guidance to all company personnel.

Regulatory Affairs

• Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals.
• Provide counsel, training and interpretation of FDA, CFDA and other regulatory requirements to all company personnel.
• Oversee preparation and filing of all regulatory documents with the FDA，CFDA and other regulatory agencies.
• Develop and maintain external relationships with key opinion leaders and regulatory officials.
• Direct the development of systems, practices and processes to ensure effective ongoing review of product design and/or manufacturing changes and adverse events.
• Provide leadership and direction for significant deviation events that may impact compliance status or represent the significant business risk.