Director, Quality Assurance and Regulatory Affairs
4 months ago
As the Director of Regulatory Compliance and Quality Assurance at Knix, you'll play a pivotal role in shaping the future of our innovative product lines. Reporting directly to the Chief Product Officer, you'll ensure that every product we create meets the highest standards of regulatory compliance and quality across all our global markets. From FDA compliance to product labeling, chemical regulations, and quality testing, you'll oversee it all. p>Overview:
- Below are the key responsibilities for this role:
- 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.
- 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.
- 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.
- Establish and maintain product quality testing protocols to ensure products meet all quality standards.
- Implement continuous improvement processes to enhance product quality.
- Ensure all product claims are substantiated by appropriate evidence.
- Oversee the development and documentation of claim substantiation processes.
- Engage with internal and external stakeholders to ensure alignment on regulatory and quality assurance matters.
- Represent the company in industry forums and regulatory meetings.
- 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. li>
- In-depth knowledge of FDA regulations and global compliance standards.
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