Vice President, Regulatory Affairs, Quality Assurance, Quality Control

Job not on LinkedIn

🕒 May 15

🗽 New York – Remote

🗽 New York – Remote

💵 $200k - $220k / year

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 40%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Venus AI LLC

WebsiteLinkedInAll Job Openings

1 - 10 employees

Founded 2023

💼 Consulting

📣 Marketing

🤖 Artificial Intelligence

Consulting • Marketing • 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, and 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 participation in inspections, audits, and regulatory meetings • Direct 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 • Perform and oversee comprehensive risk assessments and incorporate risk management activities and documentation into regulatory and quality systems • Represent Venus Concept leadership during 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 KPIs to measure departmental effectiveness, compliance, and continuous improvement • Analyze business operations and drive operational efficiencies and best-in-class regulatory and quality practices • Act as the Person Responsible for Regulatory Compliance (PRRC) under EU MDR requirements, including device conformity, technical documentation, post-market surveillance, vigilance reporting, and investigational device obligations • Serve as the Quality Management Representative, ensuring Quality Management System effectiveness, reporting to senior management, and promoting regulatory and quality awareness

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

🏖️ Benefits

• Equal opportunity employer committed to diversity and inclusion • Disability accommodations available during each stage of the recruitment process • Endless Opportunities • Opportunities to Foster Innovation • Opportunity to be part of Delivering a Best-In-Class Offering