Regulatory & Quality Specialist Jobs

The Regulatory and Quality Specialist's objective is to support the brand's growth through timely and comprehensive product registrations in international markets and stay abreast of emerging regulations to ensure the brand is positioned for successful navigation. This position is also responsible for supporting the brand's quality standards via strict adherence to established SOPs & Quality Management Systems.

The ideal candidate must be self-motivated, resourceful, and able to navigate day-to-day responsibilities independently, correctly assessing when escalation is appropriate. This individual must have excellent organization skills, with great attention to detail/accuracy, and creative, solution-oriented problem-solving skills to drive meeting deliverable deadlines in a fast-paced environment.

In This Role You Will:

• Assist with implementation completion and ongoing running of quality management system implementation per ISO 13485 EU medical device regulations and brand SOP.
• Participate in timely review of product labeling artwork for US and Global Markets.
• Help prepare regulatory SOPs and guidance documents, maintaining detailed files by product.
• Continually monitor and stay abreast of global regulatory activity affecting ingredients, product safety, and labeling, constantly assessing the potential impact on the brand.
• Continually monitor global cosmetic/drug product regulation, including The Food, Drug, and Cosmetics Act (FD&C); California Safe Cosmetic Act; The Fair Packaging and Labeling Act (FPLA); Good Manufacturing Practices (GMPs); Federal EPA and US state environmental regulations; as well as Canada, EU, UK, Australia, Middle East, and Asia cosmetic regulations.
• Help address quality issues that arise, following through to resolution and assisting with implementation and documentation of any necessary CAPA.
• Assist with global registration of medical and electronic devices.
• Communicate risk assessment and proposed recommendations for current and emerging requirements or changes within the regulatory environment working with senior management to modify strategies accordingly.
• Participate in pre-development assessment of formulations for corporate compliance, including SDS management, CARB, Proposition 65, ingredient selection, and nanotechnology.
• Review, comment, and recommend creative product claims ensuring accuracy and regulatory compliance.
• Collaborate with product development on cosmetic, OTC, professional, and medical device compliance.
• Assist in monitoring and tracking complaints, compiling data and resolutions, and following established SOP.
• Assist with completing product Dossier, gathering documents, filing registrations, formula, and label reviews.
• Help manage and track product liability claims, liaising with department heads & insurance companies.
• Collaborate with global distributors/retailers to ensure regional regulatory registrations are adequately supported, quality, and delivered according to agreed-upon business timelines.
• Help facilitate claims substantiation; collaborate cross-functionally with marketing and product development.

You'll Be Most Successful In This Role If You Have:

• Resourcefulness, securing and deploying resources effectively and efficiently.
• Communicates Effectively, developing and delivering multi-mode communications that clearly understand unique needs.
• Interpersonal Savvy, relating openly and comfortably with diverse groups of people.

Qualifications Required for Position:

• Bachelor's Degree preferred; a Master's Degree in a regulatory or health-related field a plus.
• Travel 0-5%
• Proficiency in all MS Office Programs with advanced Excel skills; QMS/Qualio, Monday.com, a plus.
• Working knowledge of US cosmetic and OTC drug regulations.
• 2-4 Specialist years of cosmetic/personal care regulatory experience with a knowledge of cosmetic ingredients.
• Medical/510K experience & Quality Assurance experience are a plus.
• Advanced oral and written professional communication skills; agile and efficient time/project management.

Work Environment

Hybrid. New York Metropolitan based. Travel: 0 – 5%

Inclusion and Diversity at Dr. Dennis Gross Skincare

At Dr. Dennis Gross Skincare, our people are our greatest asset and strength. We believe that diverse backgrounds, experiences, and perspectives result in more incredible innovation across our organization and power our capacity to address the changing beauty needs of our global consumers.

Our mission is to enable curiosity, foster vulnerability, act boldly, and demand accessibility for marginalized communities. We are committed to bringing together people from different backgrounds and providing team members with a safe, inspiring, and equitable workplace free of discrimination and harassment.

We strive to create a community where everyone can thrive, feel they matter, and do impactful work together. This is not only a commitment but a responsibility, helping us better serve our internal/external clients and partners alike.

Our Promise and Our Mission

From our Co-Founders, Dr. Dennis Gross and Carrie Gross

Whoever you are, wherever you are on your journey, Dr. Dennis Gross has the skincare expertise to deliver proven products and treatment success with the education and support you expect.

To make a difference in the lives of all people everywhere by helping them have healthier skin.