Vice President – Regulatory Affairs, Quality Assurance, Quality Control

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🕒 May 15

🗽 New York – Remote

🗽 New York – Remote

💵 $200k - $225k / year

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

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Venus AI LLC

WebsiteLinkedInAll Job Openings

1 - 10 employees

Founded 2023

🤖 Artificial Intelligence

Artificial Intelligence

Venus AI LLC is an artificial intelligence-focused company that develops and deploys AI-driven solutions and services. With an emphasis on applying machine learning and data-driven techniques, the company helps organizations automate workflows, derive insights from data, and enhance decision-making. Venus AI LLC may offer consulting, model development, and integration support to enterprise and SMB clients seeking to adopt AI technologies.

📋 Description

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

🏖️ Benefits

• Health insurance • 401(k) matching • Paid time off • Professional development opportunities