Senior Regulatory Manager, Quality
hace 2 semanas
Senior Regulatory Manager, Quality Senior Regulatory Manager, Quality at Fullscript Fullscript is a healthcare platform built on the belief that care should treat the whole person. With more than 125,000 practitioners and 10 million patients, we provide access to high‑quality supplements, industry‑leading labs, and tools that help people follow through on care. Our purpose is simple: to help people get better. What You’ll Do Lead and mentor the Regulatory team, fostering a culture of ownership, accountability, and professional growth. Oversee regulatory operations and readiness for audits and inspections across the FDA, FTC, Health Canada, CFIA, CLIA, and other authorities. Manage and maintain regulatory registrations, facility licensing, and supplier qualifications. Partner with internal teams to confirm product labeling and marketing claims across supplements, cosmetics, foods, and diagnostics. Collaborate on complaint handling, recalls, and corrective actions with Distribution, Finance, Customer Experience, and Brand teams. Work cross‑functionally with Legal, Quality, and Distribution to proactively anticipate regulatory changes and strengthen processes. Provide regulatory oversight for diagnostic laboratories and self‑collection testing kits, ensuring compliance with CLIA and related regulations. Monitor and report on key regulatory KPIs, providing performance insights and recommendations to leadership. What You Bring 10+ years of regulatory compliance experience, including 5+ years in a management role overseeing regulatory professionals. Deep working knowledge of U.S. and Canadian regulations across dietary supplements, foods, cosmetics, diagnostics, OTCs, and medical devices. Strong familiarity with FDA, Health Canada, CFIA, CLIA, FTC, and Prop 65 regulations. Experience with CGMP and NSF requirements. Proven ability to lead regulatory strategy, manage audits, and make informed decisions in high‑stakes situations. Bachelor’s degree in a life sciences field (e.g., Food Science, Biology, Biochemistry, Clinical Laboratory Science); advanced degree preferred. Exceptional leadership and communication skills, able to influence cross‑functional stakeholders. Bonus: ability to translate complex regulatory requirements into clear guidance for non‑technical stakeholders, implementation of regulatory software systems, navigating ambiguity, background in supplier or contract manufacturer auditing. Why You’ll Love Fullscript Market competitive compensation package including equity. 401(k) matching (within U.S.) / RRSP matching (within Canada). Flexible PTO policy. Employee discount on Fullscript catalog for family & friends. Ability to work wherever you work well. Values innovation—we push boundaries and always look for better ways. Supports growth—through learning, mentorship, and meaningful work. Cares about balance—with flexible work options and time off when you need it. Fullscript is an equal‑opportunity employer committed to creating an inclusive workplace. Accommodations are available upon request. Before joining the team, all candidates who receive and accept an offer will complete a background check. We 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. Seniority level: Director Employment type: Contract Industries: Outsourcing and Offshoring Consulting #J-18808-Ljbffr
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