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 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.

What you will need:

• 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 preferrable.
• Strong negotiation and stakeholder management skills.
• Proficiency with Microsoft Office and enterprise business tools.

What you will be part – our Venus Culture

Venus believes in pushing boundaries while embracing creativity and innovation. Our employees are a critical part of our company’s performance and are at the core of its success. At Venus, we rely on our employees, customers, and network of industry professionals around the world to continuously improve and Deliver the Promise. In order to do that, we ensure that everyone operates with the same values and vision. At Venus, we promise to give you Endless Opportunities, allow you to Foster Innovation and be part of Delivering a Best-In-Class Offering.

Venus is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. Venus is committed to accommodating persons with disabilities. Accommodation is available on request for qualified candidates during each stage of the recruitment process. We may use artificial intelligence (Al) tools to support parts of the hiring process.

About Venus Concept

Venus Concept is an innovative global medical aesthetic technology leader with a broad product portfolio of minimally invasive and non-invasive medical aesthetic and hair restoration technologies and reaches over 60 countries and 9 direct markets. Venus Concept's product portfolio consists of aesthetic device platforms, including Venus Versa, Venus Versa Pro, Venus Legacy, Venus Velocity, Venus Viva, Venus Glow, Venus Bliss, Venus Bliss MAX, Venus Epileve, Venus Viva MD and AI.ME. Venus Concept's hair restoration systems include NeoGraft® and the ARTAS iX® Robotic Hair Restoration system. Venus Concept is backed by Madryn Asset Management, a leading healthcare investment firm that provides capital to innovative growth-stage healthcare companies offering unique and transformative products and technologies.