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 ...