Global Chief of Regulatory Affairs & Quality Excellence

Venus Ai; New York (NY); Vor Ort; USD 300.000 - 450.000; Vollzeit

Benefits dieser Stelle

Diversity & inclusion

Disability accommodation

AI-assisted hiring

Zusammenfassung

Venus Concept in New York, NY invites a Vice President of Regulatory Affairs, Quality Assurance & Quality Control to lead global regulatory and quality strategies. You will ensure safety, compliance, and product excellence across the organization.

This executive role requires 10+ years in medical device regulatory affairs/QA, including at least 3 years at VP level, with experience in FDA submissions, EU MDR, risk management, and leading audits and inspections.

Qualifikationen

• 10+ years progressive experience in Regulatory Affairs, Quality Assurance, and/or Quality Control within the medical device industry.
• 3+ years at VP level leading enterprise-wide regulatory and quality organizations.
• Proven experience implementing, scaling, and optimizing Quality Management Systems – Arena and Salesforce proficient.

Aufgaben

• Provide executive leadership over Regulatory Affairs, Quality Assurance, and Quality Control; including budgets, hiring, performance management, and org development.
• Lead global regulatory strategy for new product development and sustaining maintenance, including FDA submissions and international approvals.
• Interface with FDA and international regulators; participate in inspections, audits, and regulatory meetings.
• Establish, maintain, and improve global Quality System policies to ensure compliance with international regulations and Venus Concept standards.
• Perform risk assessments and ensure risk management documentation is integrated into regulatory and quality systems.
• Represent Venus Concept leadership during external audits, inspections, and regulatory assessments.
• Partner with executives to set long-term strategic vision for regulatory compliance and quality excellence.
• Establish and track KPIs to measure departmental effectiveness and continuous improvement.
• Drive operational efficiencies and best-in-class regulatory and quality practices.

Kenntnisse

Regulatory affairs

Quality assurance

Quality control

Leadership

FDA submissions

EU MDR

PRRC

Arena

Salesforce

Regulatory strategy

Ausbildung

Bachelor’s or Master’s in science/engineering/healthcare

Tools

Arena

Salesforce

Jobbeschreibung

Venus Concept in New York, NY invites a Vice President of Regulatory Affairs, Quality Assurance & Quality Control to lead global regulatory and quality strategies. You will ensure safety, compliance, and product excellence across the organization.

This executive role requires 10+ years in medical device regulatory affairs/QA, including at least 3 years at VP level, with experience in FDA submissions, EU MDR, risk management, and leading audits and inspections.