Vice President, Regulatory Affairs, Quality Assurance and Quality Control

Title: Vice President, Regulatory Affairs, Quality Assurance & Quality Control Reporting to: Chief Product Officer Location: New York, NY, USA We have an exciting opportunity for a highly experienced, strategic, and performance‑driven Vice President, Regulatory Affairs, Quality Assurance & Quality Control to join our senior leadership team. This role will provide proactive global leadership across regulatory, quality, ensuring safety, compliance, product excellence, and operational rigor across the organization. The successful candidate will be a seasoned executive who has operated at a Vice President level for a minimum of 3 years, with demonstrated experience leading global, regulated medical device organizations. This leader will drive continuous improvement, scalability, and regulatory excellence to support innovation, growth, and long‑term business objectives. 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 quali