Quality & Regulatory Affairs Manager
hace 7 días
Quality & Regulatory Affairs Manager Join to apply for the Quality & Regulatory Affairs Manager role at Fullscript. About Fullscript Founded in 2013, 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. 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: Experience in a multi‑site or high‑SKU operation (distribution or manufacturing). - Bonus: Familiarity with digital QMS or regulatory systems (ZenQMS, NetSuite, etc). - Bonus: 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. - Employee discount on Fullscript catalog of products for family & friends. - Ability to work wherever you work well. Apply Now Fullscript is an equal opportunity employer committed to creating an inclusive workplace. Accommodations are available upon request. All employment offers are contingent upon the successful completion of background checks, conducted in compliance with applicable federal, state, and provincial laws. This process complies with privacy and employment laws across Canada and the U.S. Learn more about Fullscript at https://www.fullscript.com/careers. #J-*****-Ljbffr #J-18808-Ljbffr
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