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Old Toronto, Ontario, Canada Knix Full time{"Overview": "At Knix, we're revolutionizing the apparel industry with innovative products and a 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. Reporting directly to the Chief Product Officer, you'll ensure that every product we create...
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Old Toronto, Ontario, Canada Knix Full time{"Overview": "At Knix, we're revolutionizing the apparel industry with innovative products and a 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. Reporting directly to the Chief Product Officer, you'll ensure that every product we create...
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Regulatory Compliance and Quality Assurance Lead
2 months ago
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.
- 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.
