Senior Regulatory Manager, Quality

October 20

🐊 Florida – Remote

Although this job is listed in Florida, this company may be open to hiring remote in other states.

🌽 Illinois – Remote

Although this job is listed in Illinois, this company may be open to hiring remote in other states.

+2 more states

🐊 Florida – Remote 🌽 Illinois – Remote 🗻 New Hampshire – Remote 🍂 Massachusetts – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

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Fullscript

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Healthcare Insurance • Wellness • SaaS

Fullscript is a comprehensive platform that facilitates whole person care for healthcare providers. It integrates industry-leading lab testing, high-quality supplements, and a suite of tools designed to enhance patient adherence and outcomes. Fullscript offers features like personalized patient plans, evidence-based templates, patient engagement tools, and seamless wholesale ordering of supplements. The platform also integrates with top EHR systems to streamline workflows for healthcare practitioners, making it easier for them to provide effective care. With Fullscript, patients can manage their health routines more conveniently, and providers can create personalized care plans with the support of clinical evidence and insights.

201 - 500 employees

Founded 2016

⚕️ Healthcare Insurance

🧘 Wellness

☁️ SaaS

💰 $240M Private Equity Round on 2021-11

📋 Description

• 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 in partnership with Distribution, Finance, Customer Experience, and Brand teams. • Work cross-functionally with Legal, Quality, and Distribution to proactively anticipate regulatory changes and strengthen processes to ensure ongoing improvement and alignment across SOPs and documentation. • 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.

🎯 Requirements

• 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 specific to 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 455-2 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, with the ability to manage and influence cross-functional stakeholders effectively.

🏖️ Benefits

• Market competitive compensation package including equity • 401K matching (within US)//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**