Quality & Regulatory Affairs Manager Jobs

Fullscript

Location:
United States; Canada, Boston ▼
Chicago
Ottawa
Toronto

Category:
Quality Control

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

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 455-2, 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.

Job Responsibility:

Maintain ongoing compliance with FDA 21 CFR 111, DSHEA, and NSF 455-2 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

Requirements:

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 455-2) 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

Nice to 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

What we offer:

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*

Additional Information:

Job Posted:
December 08, 2025

Employment Type:

Fulltime

Work Type:

Remote work

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Quality & Regulatory Affairs Manager