Regulatory Affairs Manager (Medtech)

TL;DR

Regulatory Affairs Manager (Medtech): Supporting content and compliance processes for microbiome health products with an accent on FDA/FTC compliance and claims substantiation. Focus on executing technical regulatory reviews, maintaining documentation, and integrating generative AI into RA workflows.

Location: Must be based in the US (100% remote-US)

Salary: $145k-$160k

Company

Microbiome science company pioneering clinically validated innovations for gut and whole-body health.

What you will do

• Conduct ingredient, formula, and packaging compliance reviews according to US FDCA, DSHEA, and 21 CFR frameworks.
• Generate and maintain raw material compliance documentation, including GRAS, ODI, and NDIN status.
• Execute compliance reviews for FTC and FDA claims and product substantiation.
• Serve as the primary regulatory contact for Brand, Creative, and Marketing teams to triage and resolve review requests.
• Develop and optimize SOPs for regulatory review processes and integrate RA into generative AI workflows.
• Support GMP compliance and audit readiness by reviewing QMS records, labels, and specifications.

Requirements

• Minimum 6 years experience in Regulatory Affairs in a GMP environment.
• Minimum 4 years experience executing technical regulatory reviews in dietary supplements for the U.S.
• B.Sc. in pharmaceutical, nutritional, or life sciences or a related scientific field.
• Strong knowledge of FDA regulations (21 CFR 111, FSMA) and FTC advertising rules.
• Expertise in dietary supplement labeling and GMP product documentation requirements.
• Must be based in the United States.

Nice to have

• Experience working with live microbials or probiotic products.
• Experience supporting GMP inspection documentation requests.
• Knowledge of international food supplement regulations in the EU, Canada, or Australia.

Culture & Benefits

• Remote-first culture prioritizing autonomy and clarity with a $750 setup stipend.
• Comprehensive health, dental, and vision plans with employer contributions and HSA options.
• 401(k) plan with 100% match on the first 3% and 50% on the next 2%, fully vested from day one.
• Generous time off: 18 weeks paid parental leave, 15 vacation days, 7 sick days, and 10 Recharge Days.
• Mental health support including 12 free therapy sessions per year via Spring Health.
• Quarterly wellness and workplace stipends via JOON.