Quality & Regulatory Affairs Manager
hace 7 días
Quality & Regulatory Affairs Manager at Fullscript Founded in ****, Fullscript provides a health intelligence platform that powers every part of care for 125,000 practitioners and supports over 10 million patients. 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 who can 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 (U.S.) and RRSP matching (CAD). - Flexible PTO policy. - Employee discount on Fullscript catalog of products for family & friends. - Ability to Work Wherever You Work Well. Equal Opportunity Fullscript is an equal‑opportunity employer committed to creating an inclusive workplace. Accommodations are available upon request. All employment offers are contingent upon successful completion of background checks, conducted in compliance with applicable federal, state, and provincial laws. #J-18808-Ljbffr
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Quality & Regulatory Affairs Manager
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Tigre, Argentina Fullscript A tiempo completoQuality & Regulatory Affairs Manager at Fullscript Founded in ****, Fullscript provides a health intelligence platform that powers every part of care for 125,000 practitioners and supports over 10 million patients. What You’ll Do Maintain ongoing compliance with FDA 21 CFR 111, DSHEA, and NSF ***** for finished dietary supplements. Manage Health Canada...
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Tigre, Argentina Fullscript A tiempo completoA health intelligence platform provider is seeking a Quality & Regulatory Affairs Manager to ensure compliance with FDA and Health Canada regulations for dietary supplements. Responsibilities include managing licensing and inspections, overseeing supplier qualifications, and contributing to compliance initiatives. The ideal candidate has over 5 years of...
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