Director, Regulatory Affairs
Knix Wear
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- 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.
This job is no longer accepting applications
See open jobs at Knix Wear.See open jobs similar to "Director, Regulatory Affairs" Work In Tech.