Director, Regulatory Affairs

Posted 2025-04-06
Remote, USA Full-time Immediate Start

Knix is an award-winning intimate apparel and activewear brand that is re-inventing intimates for real life. Through our innovative products and our engaged community, we are empowering people everywhere to be unapologetically free. Launched in 2013, we are one of the fastest-growing intimate apparel brands in North America and are globally recognized as an innovator within the apparel space. We reach over 3 million customers through our online stores, Knix retail locations across North America and channels such as wholesale and Amazon. We are revolutionizing the apparel industry with our best-in-class customer experience, innovative products and brands Knix and Kt by Knix. Come join us if you are looking for a purpose-driven and authentic career!

As the Director of Regulatory Compliance at Knix, you'll play a pivotal role in shaping the future of our innovative product lines. Reporting directly to the Associate General Counsel, you'll ensure that every product we create meets the highest standards of regulatory compliance across all our global markets. From FDA compliance to product labeling, compliance with evolving apparel regulations, and EPR guidelines, you'll oversee it all. This role is perfect for a leader with a global perspective and the ability to inspire and advise diverse stakeholders.

If you’re passionate about ensuring products meet rigorous standards while driving innovation, this is the opportunity for you to make a significant impact at Knix.

About This Job

  • Regulatory Compliance for Apparel and Medical Devices: Ensure compliance with all applicable regulations and standards in all intended markets of sale, including but not limited to FDA and Health Canada requirements.Design and implement strategies to efficiently comply with diverse regulatory requirements in applicable markets.Monitor and interpret regulatory developments and communicate their implications to stakeholders across the organization.Ability to liaise with regulators and regulatory networks to stay abreast of updates and anticipated updates to regulations.
  • 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 ingredients disclosure compliance for medical devices and other regulated products.
  • Claim Substantiation:Collaborate with Legal, Quality, Product and Marketing teams to ensure bold and exciting product performance claims are substantiated.
  • Stakeholder Engagement:Engage with internal and external stakeholders to ensure alignment on regulatory issues.Translate compliance requirements for colleagues simple, effective and actionable communication on related matters.Represent Knix in industry forums and regulatory meetings.
  • Leadership and Management:Foster a culture of compliance across stakeholder groups within the organization.Advise the business on the level of risk associated with evolving regulations
  • Qualifications:

  • 6-10 years of experience in regulatory compliance and quality assurance, with deep exposure in the apparel industry, cosmetics, food, pharmaceutical or similar.
  • Bachelor’s degree in Regulatory Affairs, Quality Assurance, or a related field. Advanced degree is an asset.
  • In-depth knowledge of FDA medical device regulations, Health Canada guidelines, textile labelling requirements and global compliance standards.
  • Critically understands and applies regulations to a practical environment.
  • Ability to influence and advise on priorities.
  • Executes independently and operates autonomously.
  • Looks to keep work in house and effectively manage costs.
  • 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.
  • Additional Information

    How we Hire

    Our people are what make Knix, Knix! Our people are passionate and have a strong belief in our mission. Our people are naturally curious and ambitious by nature. Employees feel respected and supported at Knix. We take an inclusive and equitable approach offering the same interview experience to every candidate we meet with. Knix is an equal opportunity employer, we celebrate everyone and their intersecting identities. We know and believe that diverse and inclusive teams empower us to make better decisions and inspire innovation so that we can better serve our customers and community. We are committed to providing reasonable accommodations and will work with you to meet your needs. If you are a person with a disability and require assistance during the application process, please don’t hesitate to reach out! We celebrate our inclusive work environment and welcome members of all backgrounds and perspectives to apply.

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