Vice President, Regulatory Affairs, Quality Assurance, Quality Control

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Provide executive leadership and oversight for Regulatory Affairs, Quality Assurance, and Quality Control, encompassing budgeting, hiring, performance management, and organizational development.

• Lead and implement the global regulatory strategy for both new product development and ongoing product maintenance, including FDA submissions as well as international product approvals and renewals.

• Act as the executive liaison with the FDA and international regulatory bodies, with direct involvement in inspections, audits, and regulatory meetings.

• Oversee all facets of regulatory affairs strategy and quality assurance for new product development and maintenance, focusing on risk management and technical documentation.

• Develop, maintain, and continuously enhance global Quality System policies and procedures to ensure compliance with relevant international regulations, directives, and standards for Venus Concept products and services.

• Conduct and supervise thorough risk assessments, ensuring that risk management activities and documentation are integrated into regulatory and quality systems.

• Represent Venus Concept leadership during all external audits, inspections, and regulatory evaluations.

• Collaborate with executive leadership to define and implement the long-term strategic vision for regulatory compliance and quality excellence.

• Establish and monitor Key Performance Indicators (KPIs) to assess departmental effectiveness, compliance, and ongoing improvement.

• Perform regular analyses of business operations to enhance operational efficiencies and adopt best-in-class regulatory and quality practices.

• Serve as the Person Responsible for Regulatory Compliance (PRRC) in line with EU MDR requirements, covering device conformity, technical documentation, post-market surveillance, vigilance reporting, and investigational device obligations.

• Act as the Quality Management Representative, ensuring the Quality Management System's effectiveness, reporting to senior management, and fostering regulatory and quality awareness throughout the organization.

⛳️ Requirements

• Bachelor’s or Master’s degree in a scientific, engineering, or healthcare-related field.

• At least 10+ years of progressive experience in Regulatory Affairs, Quality Assurance, and/or Quality Control within the medical device sector.

• Minimum of 3+ years in a Vice President role, leading comprehensive regulatory and quality organizations.

• Proven track record in identifying, developing, and mentoring talent.

• Demonstrated experience in implementing, scaling, and optimizing Quality Management Systems – proficiency in Arena and Salesforce is required.

• In-depth knowledge of FDA and international regulatory submissions, including EU MDR.

• Strong verbal and written communication skills suitable for executive-level interactions.

• Excellent interpersonal abilities with a talent for cross-functional influence.

• Experience in the medical device field is essential, with a preference for candidates with medical aesthetic experience.

• Proficiency in Microsoft Office and other enterprise business tools.

🏝️ Benefits

• Venus is an equal opportunity employer dedicated to diversity and inclusion.

• Accommodation is available upon request for qualified candidates throughout each stage of the recruitment process.