Vice President, Regulatory Affairs, Quality Assurance, Quality Control

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🕒 Maio 15

🍂 Massachusetts – Remoto

🍂 Massachusetts – Remote

💵 $200.000 - $225.000 / ano

⏰ Tempo Integral

🔴 Especialista

🔧 Engenheiro de QA (Qualidade de Software)

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Venus AI LLC

SiteLinkedInTodas as Vagas

1 - 10 funcionários

Fundada em 2023

🤖 Inteligência Artificial

Artificial Intelligence

A Venus AI LLC é uma empresa focada em inteligência artificial que desenvolve e implementa soluções e serviços impulsionados por IA. Com ênfase na aplicação de aprendizado de máquina e técnicas orientadas por dados, a empresa ajuda as organizações a automatizar fluxos de trabalho, extrair insights de dados e melhorar a tomada de decisões. A Venus AI LLC pode oferecer consultoria, desenvolvimento de modelos e suporte à integração para clientes corporativos e de pequenas e médias empresas que buscam adotar tecnologias de IA.

Descrição

• 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.

🎯 Requisitos

• 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. • 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. • Medical device experience is a must – medical aesthetic experience is preferrable. • Proficiency with Microsoft Office and enterprise business tools.

🏖️ Benefícios

• Venus is an equal opportunity employer committed to diversity and inclusion. • Accommodation is available on request for qualified candidates during each stage of the recruitment process.