Venus AI LLC

QA Engineer

• 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.

Vice President – Regulatory Affairs, Quality Assurance, Quality Control

• 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.

Vice President, Regulatory Affairs, Quality Assurance, Quality Control

Account Manager

• Drive sales growth for new customers; increase customer base and market share.
• Conduct prospect analysis, understand their business, their opportunities, and gaps.
• Conduct a minimum of 30 cold calls daily, book 5 meetings daily and run 2-3 meetings daily.
• Establish, develop, and maintain positive business and customer relationships; visit all accounts regularly and ensure customer satisfaction.
• Meet sales targets as set through annual/quarterly budgets.

Vice President – Regulatory Affairs, Quality Assurance, Quality Control

Vice President, Regulatory Affairs, Quality Assurance, Quality Control

Territory Manager