Regulatory Compliance and Quality Assurance Lead

1 week ago

Old Toronto, Ontario, Canada Knix Full time

At Knix, we're revolutionizing the apparel industry with our innovative products and best-in-class customer experience. As the Director of Regulatory Compliance and Quality Assurance, you'll play a pivotal role in shaping the future of our product lines.

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.
Qualifications:
  • 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.
  • In-depth knowledge of FDA regulations and global compliance standards.
  • Manages multiple projects efficiently, ensuring every detail is noticed.
  • Proven leadership and team management skills.

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