Confidential · 4 weeks ago
Quality Assurance Regulatory Affairs Manager
New York, NY
Full-time
Onsite
Mid, Senior Level
$110K/yr - $130K/yr
3+ years expConfidential is a fast-growing, PE-backed consumer health & wellness company seeking a Regulatory Affairs-focused QA/RA Manager to lead regulatory strategy and product submissions. This hands-on role involves ensuring compliance across a broad sexual wellness and consumer health portfolio while driving innovation and speed to market.
Staffing & Recruiting
Responsibilities
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
Qualification
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
Spanish or French a plus
Benefits
Benefits
Company
Confidential
Centralizing All Types Of Next Opportunities For You In One Place.
Vancouver, US
2-10 employeesFunding
Current Stage
Early StageCompany data provided by crunchbase