Vice President, Regulatory Affairs, Quality Assurance and Quality Control

About the role

We are seeking a highly experienced 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.

Responsibilities

• 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 to ensure compliance with applicable international regulations, directives, and standards related to Venus Concept products and services.
• Perform and oversee comprehensive risk assessments, ensuring risk management activities and documentation are incorporated into regulatory and quality systems.
• Represent Venus Concept leadership during all external audits, inspections, and regulatory assessments.
• Partner with executive leadership to establish and execute the long-term strategic vision for regulatory compliance and quality excellence.
• Establish and track Key Performance Indicators (KPIs) to measure departmental effectiveness, compliance, and continuous improvement.
• Conduct regular analyses of business operations, driving operational efficiencies and best-in-class regulatory and quality practices.
• Act as the Person Responsible for Regulatory Compliance (PRRC) in accordance with EU MDR requirements, including device conformity, technical documentation, post-market surveillance, vigilance reporting, and investigational device obligations.
• Serve as the Quality Management Representative, ensuring the effectiveness of the Quality Management System, reporting to senior management, and promoting regulatory and quality awareness across the organization.

Requirements

• Bachelor’s or Master’s degree in a scientific, engineering, or healthcare-related discipline.
• Minimum 10+ years of progressive experience in Regulatory Affairs, Quality Assurance, and/or Quality Control within the medical device industry.
• Mandatory: 3+ years of experience performing this role at the Vice President level, leading enterprise-wide regulatory and quality organizations.
• Demonstrated success identifying, developing, and mentoring talent.
• Proven experience implementing, scaling, and optimizing Quality Management Systems – must be proficient in Arena and Salesforce.
• Deep expertise in FDA and international regulatory submissions, including EU MDR.
• Strong executive-level verbal and written communication skills.
• Excellent interpersonal skills with the ability to influence cross-functionally.
• Collaborative leadership style with the ability to promote regulatory and quality excellence across the organization.
• Medical device experience is a must – medical aesthetic experience is preferred.
• Strong negotiation and stakeholder management skills.
• Proficiency with Microsoft Office and enterprise business tools.