Quality Assurance Regulatory Affairs Manager

Regulatory Affairs Quality Assurance Manager – North America | $110,000–$130,000 + benefits 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. Regulatory Affairs (Primary Focus) 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. Quality Assurance (Secondary Focus) 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. Qualifications Required 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 Preferred 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. #J-18808-Ljbffr Confidential