Quality Assurance Regulatory Affairs Manager

Quality Assurance Regulatory Affairs Manager

Base pay range: $/yr - $/yr

A fast‑growing, PE‑backed consumer health & wellness company is seeking a Regulatory Affairs–focused QA/RA Manager to lead regulatory strategy, product submissions, labeling compliance, and global market readiness across a broad sexual wellness and consumer health portfolio. This is a hands‑on RA role, ideal for someone who thrives in a lean, entrepreneurial environment, driving compliant innovation and speed to market.

• Lead regulatory strategy for U.S. and international markets across medical device and consumer health products.
• Prepare, submit, and maintain 510(k) s, global registrations, and technical documentation.
• Manage labeling, packaging, and claims to ensure full regulatory and substantiation compliance.
• Maintain and update GUDID, FURLS, ITACS, and other regulatory databases.
• Monitor and interpret FDA, FTC, Health Canada, and global regulatory changes, advising leadership on risks and opportunities.
• Partner with R&D, Marketing, Legal, and Supply Chain to guide product development and ensure compliant launches.

• Support maintenance of a scalable QMS appropriate for a lean medical device environment.
• Contribute to supplier oversight, product testing coordination, and complaint handling as needed.
• Promote regulatory‑driven quality culture across the business.

• Bachelor’s in Life Sciences, Chemistry, Engineering, or related field.
• 3–5+ years’ regulatory affairs experience in medical devices, consumer health, or adjacent categories.
• Hands‑on experience with 510(k) submissions, regulatory databases (GUDID, FURLS, ITACS), labeling compliance, and claims review.
• Strong understanding of FDA and FTC regulations and global market pathways.
• Ability to operate in a lean, fast‑growth, entrepreneurial CPG environment.
• Excellent communication and cross‑functional partnering skills.

• RAC certification or advanced regulatory training.
• Experience with cosmetics, OTC, or mixed‑portfolio consumer wellness brands.
• Familiarity with digital commerce compliance and ethical marketing standards.
• Spanish or French a plus.

Mid‑Senior level

Full‑time

Quality Assurance

Consumer Services, Retail Pharmacies, and Retail Luxury Goods and Jewelry