Vice President, Regulatory Affairs, Quality Assurance and Quality Control

Vice President, Regulatory Affairs, Quality Assurance & Quality Control Reporting to: Chief Product Officer Location: Toronto, Canada or East Coast, USA What you will do

Provide executive leadership and oversight of Regulatory Affairs, Quality Assurance, Quality Control; including budgets, hiring, performance management, and organizational development. Lead and execute global regulatory strategy for new product development and sustaining product maintenance, including FDA submissions and international product approvals and renewals. Serve as the executive interface with the FDA and international regulatory authorities, including direct participation in inspections, audits, and regulatory meetings. Direct all aspects of regulatory affairs strategy and quality assurance for new product development and sustaining product maintenance, including risk management and technical documentation. Establish, maintain, and continuously improve global Quality System policies and procedures t...