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Regulatory Compliance and Quality Assurance Director

2 months ago


Old Toronto, Ontario, Canada Knix Full time
About the Role

We are seeking a highly skilled and experienced Director of Regulatory Compliance and Quality Assurance to join our team at Knix. As a key member of our organization, you will play a pivotal role in shaping the future of our innovative product lines and ensuring that every product we create meets the highest standards of regulatory compliance and quality across all our global markets.

Key Responsibilities
  • Regulatory Compliance: Ensure compliance with all relevant regulations and standards in all intended markets of sale, including but not limited to FDA requirements. Develop and implement regulatory strategies and processes to ensure product compliance. Monitor and interpret regulatory developments and communicate their implications to the organization.
  • Product Labeling and Packaging: Oversee the creation and review of product labels and packaging to ensure compliance with regulatory requirements. Ensure accuracy and completeness of product information on labels and packaging.
  • Chemical Compliance: Track and implement regulations related to chemical compliance. Develop and manage testing programs for chemical compliance. Ensure full ingredient disclosure for medical devices and other regulated products.
  • Product Quality Testing: Establish and maintain product quality testing protocols to ensure products meet all quality standards. Implement continuous improvement processes to enhance product quality.
  • Claim Substantiation: Ensure all product claims are substantiated by appropriate evidence. Oversee the development and documentation of claim substantiation processes.
  • Stakeholder Engagement: Engage with internal and external stakeholders to ensure alignment on regulatory and quality assurance matters. Represent the company in industry forums and regulatory meetings.
  • Leadership and Management: Lead and manage a diverse team of compliance and quality assurance professionals, playing a key role in their learning and development. Foster a culture of compliance and quality within the organization. Adapt strategies to meet the diverse regulatory requirements of different markets.
Requirements
  • 6-10 years of experience in regulatory compliance and quality assurance, with deep exposure in the apparel industry.
  • Bachelor's degree in Regulatory Affairs, Quality Assurance, or a related field. Advanced degree preferred.
  • In-depth knowledge of FDA regulations and global compliance standards.
  • Ability to stay organized and proactively find answers to emerging questions. Continuously seeks new knowledge on regulatory compliance, staying ahead with up-to-date information.
  • Manages multiple projects efficiently, ensuring every detail is noticed.
  • Proven leadership and team management skills.
  • Strong analytical and problem-solving abilities.
  • Excellent communication and interpersonal skills.