Director of Quality and Compliance at Trinity Health managing quality improvement plans and compliance oversight in healthcare operations. Collaborating with teams to drive quality initiatives and ensure regulatory compliance.
About the role
- Director of Regulatory Affairs managing compliance aspects of beauty product regulations for Luxury Brand Partners. Collaborating with teams to register products and maintain quality assurance.
Responsibilities
- Manage all regulatory compliance aspects of our business
- Ensure formulas and packaging are compliant with regulations in countries in which products are sold
- Registering new products both domestically and internationally
- Oversee product testing and quality assurance
- Collaborate with product development, packaging, operations, and finance/legal, as well as outside advisors
- Stay up to date with regulatory changes impacting ingredients and products
- Ensure all products are in compliance with domestic and international regulatory, environmental and hazmat shipping regulations
- Author & maintain Safety Data Sheets, NAFTA certificates, handle regulatory filings and necessary updates to regulatory filings in each market
- Manage FDA registrations to ensure company compliance with new MOCRA regulations
- Support PD with performing product name trademark searches and compliant product descriptions based on global market requirements
- Work closely with PD to evaluate product and packaging copy and providing feedback and recommended verbiage to ensure claims and verbiage are legal and substantiated
- Risk-assess every product launch (ie formula, product copy, claims, packaging labeling, marketing claims, etc) and call-out any potential concerns
- Generate ingredient lists for labeling of all products
- Perform artwork/label review from both a technical and claims perspective
- Address all product and regulatory questions from the team
- Approval of all product claims and consumer-facing marketing copy
- Perform all OTC evaluations and provide guidance to the team on process and requirements, including development, testing, labeling, copy/claims, FDA registration, launch, complaints, etc
- Compile documentation and maintain European regulatory Product Information Files for each product
- Oversee processes and advise on entering new markets from a regulatory standpoint
- Recommend and oversee quality assurance programs
- Oversee product safety, stability and claims testing (Micro, safety, RIPT)
- Advocate for the company with industry associations and represent Luxury Brand Partners and its brands in industry groups
Requirements
- 10+ years of industry experience in regulatory affairs
- Beauty, Skin Care, Hair Care and/or CPG experience a plus
- Master’s degree in scientific discipline such as chemistry, biology, toxicology or environmental science is a plus
- Expert understanding of global cosmetic and chemical regulations
- Extensive knowledge of safety regulations and industry standards relating to a variety of consumer products in the US, EU and Canada
- Product development experience is a plus
- OTC experience is a plus
- Established industry relationships
- Excellent verbal & written communication and organizational skills
- Extremely detail-oriented
- Strategic thinker who blends strong analytics and creativity and curiosity
- Strong work ethic and can-do attitude
- Problem solving and entrepreneurial in nature
- Ability to manage multiple projects and priorities simultaneously
- Strong team player
- Thrive in a fast-paced entrepreneurial environment
Benefits
- Comprehensive health, dental, and vision insurance along with additional ancillary benefits
- Flexible spending and health savings accounts (FSA/HSA)
- Employer paid life insurance coverage with optional supplemental life insurance available
- Employer paid long-term and short-term disability
- Access to Employee Assistance Program (EAP)
- Starting with 10 vacation days, 4 fixed personal days and 5 sick days (unless state law requires otherwise, in which case we will comply with state law)
- Twelve paid holidays
- Paid parental leave
- Summer Fridays between Memorial Day & Labor Day
- 401(k) with company match
- Monthly technology allowance
- Eligible for annual discretionary bonus
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