Quality & Regulatory Affairs Manager

Quality & Regulatory Affairs Manager Join to apply for the Quality & Regulatory Affairs Manager role at Fullscript. 1 week ago Be among the first 25 applicants. About Fullscript Founded in ****, Fullscript started by solving one problem: helping practitioners access and prescribe the products they trust to deliver integrative care. What began as a simple solution has evolved into a health intelligence platform that powers every part of care. Today, 125,000 practitioners rely on Fullscript for clinical insights, lab interpretations, patient analytics, education, and access to high-quality supplements. They support over 10 million patients who use Fullscript to stay connected to their care plans, making it easier to stay engaged and follow through on treatment. We build tools that make care smarter and more human. Tools that save time, simplify decisions, and strengthen the connection between practitioner and patient. When everything practitioners need is in one place, they can focus on what matters most: helping people get better. Bring your ideas. Bring your grit. Bring your care for people. Join us and shape the future of care. We're looking for a Quality & Regulatory Affairs Manager who's passionate about dietary supplement and NHP compliance and ready to help drive end-to-end regulatory operations across North America. You'll be hands‑on with FDA 21 CFR Part 111, DSHEA, NSF *****, and Health Canada's NHP regulations with the ultimate goal of ensuring our products, warehouses, and documentation consistently meet the highest standards while every process stands up to regulatory scrutiny. This is a hands‑on, high‑visibility role where you'll partner closely with Quality, Legal, and Distribution teams to keep our systems inspection‑ready and our documentation watertight. You'll work across a fast‑moving operation with more than 17,000 SKUs and five warehouses, maintaining our commitment to flawless compliance as we continue to scale. It's an excellent opportunity for someone who enjoys solving complex compliance challenges, leading through influence, and is eager to grow into broader leadership as our team expands. Join us to build the next chapter of Fullscript's regulatory journey What You'll Do - Maintain ongoing compliance with FDA 21 CFR 111, DSHEA, and NSF ***** for finished dietary supplements. - Manage Health Canada NHP site and product licensing, importation compliance, and regulatory documentation. - Review and approve labels, claims, and substantiation for dietary supplements and NHPs. - Support audit readiness for FDA, NSF, and Health Canada inspections, including CAPA documentation and process follow‑up. - Oversee facility registrations, supplier qualifications, and product listings across U.S. and Canadian markets. - Partner with Quality, Legal, and Distribution to resolve compliance issues and strengthen product lifecycle controls. - Monitor regulatory updates and proactively align internal processes to new requirements. - Contribute to SOP, QMS, and continuous improvement initiatives that reinforce Fullscript's compliance excellence. What You Bring - 5+ years of progressive experience in regulatory affairs or quality compliance within dietary supplements and/or NHPs. - Working knowledge of FDA dietary supplement regulations (21 CFR 111, DSHEA, NSF *****) and Health Canada NHP frameworks. - Experience supporting or preparing for FDA, NSF, or Health Canada inspections. - Proven ability to manage labeling, claims, supplier documentation, and GMP records with precision. - Strong communicator with the confidence to collaborate across teams and influence without authority. - Bachelor's degree in life sciences, chemistry, or a related field. - Bonus if you have: - Experience in a multi‑site or high‑SKU operation (distribution or manufacturing). - Familiarity with digital QMS or regulatory systems (ZenQMS, NetSuite, etc). - Knowledge of Prop 65 or FTC claim substantiation. Why You'll Love Fullscript Market‑competitive compensation package including equity. 401 K matching (within U.S.)//RRSP matching (within CAD). Flexible PTO policy. Flexible Benefits Package And Additional Perks - Employee discount on Fullscript catalog of products for family & friends. - Ability to Work Wherever You Work Well. Why Fullscript Great work happens when people feel supported, trusted, and inspired. You’ll Join a Team That - Values innovation. - We stay curious and keep finding smarter ways to make care better. - Supports growth. - We learn together and take on new challenges that drive impact. - Puts people first. - We win as a team and leave egos at the door. A Few Things to Know We're grateful for the high level of interest in joining Fullscript. Because of the number of messages we receive, we're not able to review or respond to individual inquiries about open roles via email, LinkedIn, or other social platforms. Please apply directly through our careers page to ensure your application reaches our hiring team. Fullscript is an equal‑opportunity employer committed to creating an inclusive workplace. Accommodations are available upon request. Email ****** for support. All employment offers are contingent upon the successful completion of background checks, conducted in compliance with applicable federal, state, and provincial laws. We also use AI tools to support parts of our hiring process, like screening and reviewing responses. Final decisions are always made by people. This process complies with privacy and employment laws across Canada and the U.S. Learn more about Fullscript. @fullscriptHQ on instagram. Let's make healthcare whole. Tigre, Buenos Aires Province, Argentina. 1 month ago. Referrals increase your chances of interviewing at Fullscript by 2x. Seniority level Mid‑Senior level Employment type Full‑time Job function Quality Assurance Industries Writing and Editing #J-18808-Ljbffr