Vice President – Regulatory Affairs, Quality Assurance, Quality Control
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Job Description
Vice President managing regulatory affairs and quality control at a global medical technology leader. Executing global strategies and overseeing compliance and quality excellence.
Responsibilities:
- 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
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