Vice President, Regulatory Affairs, Quality Assurance, Quality Control

📋 Description

• Provide strategic leadership and oversight for Regulatory Affairs, Quality Assurance, and Quality Control, encompassing budgets, recruitment, performance management, and organizational growth.

• Develop and implement a global regulatory strategy for both new product development and ongoing product maintenance, which includes FDA submissions and international approvals and renewals.

• Act as the executive liaison with the FDA and other international regulatory bodies, participating directly in inspections, audits, and regulatory meetings.

• Manage all facets of regulatory affairs strategy and quality assurance for new product initiatives and ongoing product support, focusing on risk management and technical documentation.

• Create, uphold, and continuously enhance global Quality System policies and procedures to guarantee compliance with relevant international regulations, directives, and standards associated with Venus Concept products and services.

• Conduct and oversee thorough risk assessments, ensuring that risk management activities and documentation are integrated into regulatory and quality systems.

• Represent Venus Concept’s leadership during all external audits, inspections, and regulatory evaluations.

• Collaborate with executive leadership to establish and implement the long-term strategic vision for regulatory compliance and quality excellence.

• Set and monitor Key Performance Indicators (KPIs) to assess departmental efficiency, compliance, and ongoing improvement.

• Perform regular analyses of business operations to enhance operational efficiencies and establish best-in-class regulatory and quality practices.

• Serve as the Person Responsible for Regulatory Compliance (PRRC) in line with EU MDR requirements, covering device conformity, technical documentation, post-market surveillance, vigilance reporting, and investigational device responsibilities.

• Act as the Quality Management Representative, ensuring the effectiveness of the Quality Management System, reporting to senior management, and fostering regulatory and quality awareness throughout the organization.

⛳️ Requirements

• Bachelor's or Master's degree in a scientific, engineering, or healthcare-related field.

• A minimum of 10+ years of progressive experience in Regulatory Affairs, Quality Assurance, and/or Quality Control within the medical device sector.

• Required: At least 3+ years of experience in a similar role at the Vice President level, leading regulatory and quality organizations across the enterprise.

• Proven success in identifying, developing, and mentoring talent.

• Demonstrated experience in implementing, scaling, and optimizing Quality Management Systems – proficiency in Arena and Salesforce is essential.

• Extensive knowledge of FDA and international regulatory submissions, including EU MDR.

• Strong verbal and written communication skills at the executive level.

• Excellent interpersonal abilities with a talent for influencing cross-functional teams.

• A collaborative leadership approach that promotes regulatory and quality excellence throughout the organization.

• Experience in the medical device field is essential; experience in medical aesthetics is preferred.

• Strong negotiation and stakeholder management capabilities.

• Competence in Microsoft Office and other enterprise business tools.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Paid time off

• Professional development opportunities