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.


  • 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.

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