Senior Director overseeing Quality & Regulatory Strategy for innovative medical device company. Partnering with executives to drive compliance and operational excellence in a regulated environment.
About the role
- Quality & Regulatory Manager ensuring product quality and regulatory compliance in CPG. Collaborating with cross-functional teams to drive continuous improvement and support product innovation.
Responsibilities
- Develop, implement, and maintain quality systems aligned with industry standards (e.g., ISO, GMP, HACCP).
- Lead internal and supplier audits, manage CAPAs, and ensure timely resolution of quality issues.
- Monitor product quality metrics and drive root cause analysis and continuous improvement.
- Collaborate with manufacturing and operations teams to ensure quality is embedded in production processes.
- Maintain and improve document control systems and SOPs.
- Ensure compliance with FDA, EPA, FTC, and other relevant regulatory bodies for all product categories.
- Manage product registrations, certifications, and regulatory documentation for domestic and international markets.
- Review and approve product labels, claims, and marketing materials for regulatory accuracy.
- Monitor regulatory changes and communicate implications to internal stakeholders.
- Coordinate with legal and external consultants for regulatory submissions and audits.
- Lead cross-functional projects related to product launches, quality improvements, and regulatory initiatives.
- Develop and manage project plans, timelines, budgets, and resource allocations.
- Track project progress, identify risks, and implement mitigation strategies.
- Facilitate communication and alignment between Operations, Marketing, and Supply Chain teams.
- Partner with Product Development, Marketing, Creative and teams during product development to ensure quality and regulatory considerations are integrated early.
- Review product formulations and packaging for compliance and quality standards.
- Support pilot runs and scale-up activities with quality oversight.
- Provide guidance on regulatory pathways for new product categories or markets.
Requirements
- Bachelor’s degree in a scientific discipline.
- 5+ years of experience in quality, regulatory, or compliance roles within the CPG industry.
- Experience supporting product development and commercialization processes.
- Strong knowledge of FDA, EPA, and other regulatory frameworks.
- Project Management.
- Excellent communication, leadership, and problem-solving skills.
- Proficiency in quality systems, document control, and project management tools.
Benefits
- health insurance
- retirement plans
- paid time off
Job title
Job type
Experience level
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Not specified
Degree requirement
Location requirements
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