Director, Quality & Regulatory

Responsibilities

• Develop and execute our quality and regulatory strategy, set departmental goals, and manage the department's budget and expenses
• Lead, mentor, and develop the quality assurance and regulatory affairs team while fostering a culture of quality across the organization
• Report quality and compliance performance to executive leadership and partner cross-functionally with product development, marketing, legal, and customer experience teams
• Develop, implement, and maintain the QMS, including quality policies, procedures, and document control systems
• Ensure ongoing compliance with all relevant quality standards
• Define product quality standards, acceptance criteria, and reliability/durability testing requirements, and ensure products meet specifications
• Establish audit criteria for suppliers/contract manufacturers and oversee incoming, in-process, and finished goods quality, including review of statistical quality data and validation/verification activities
• Ensure domestic and international regulatory compliance for both wet goods and hard goods, interpreting new requirements and developing compliance strategies
• Maintain regulatory files and technical documentation, coordinate submissions, and monitor regulatory changes affecting products
• Lead product safety programs, ensure products meet safety standards, and manage safety certifications and third-party testing
• Investigate product safety complaints and participate in recall planning when necessary
• Develop supplier quality requirements, qualify and approve suppliers, and conduct supplier audits and performance evaluations
• Establish incoming inspection requirements, review supplier corrective actions, and partner with suppliers to resolve quality issues and drive improvement
• Participate in product development planning, review and approve specifications, and ensure quality is designed into new products
• Review product testing, approve production readiness, and support product launch activities
• Identify quality risks, conduct risk assessments, and develop mitigation plans
• Analyze customer complaints, investigate warranty issues, and develop corrective action plans while monitoring customer quality metrics to drive improved satisfaction
• Maintain department records and data, ensure retention requirements are met, and keep records inspection-ready
• Train relevant departments on regulatory requirements and ensure regulatory impacts are considered throughout product development

Qualifications

• Bachelor’s degree in engineering, quality, manufacturing, regulatory affairs or related business field
• 10+ years of progressive experience in product quality and/or regulatory affairs for a consumer products brand with demonstrated ownership of QMS development, product safety programs, and domestic/international regulatory compliance
• Proven experience leading and developing quality assurance and/or regulatory affairs team members, including setting departmental goals, mentoring staff, and building a culture of quality
• Strong organizational and communication skills with proven ability to report quality and compliance performance to executive leadership and translate complex regulatory requirements into clear guidance for cross-functional teams
• Recent experience with consumer products required, including defining quality standards, overseeing product validation, and managing reliability and durability testing throughout the product development lifecycle
• Experience working with a global supplier base, establishing supplier quality requirements, auditing suppliers, evaluating performance, and driving continuous improvement
• Experience managing a departmental budget and operational expenses, with the business acumen to balance quality/compliance investment against organizational priorities and risk