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.

• 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.

• 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…