Quality Assurance Regulatory Affairs Manager

Confidential; New York (NY); On-site; USD 110,000 - 130,000; Full time

Benefits offered by this job

Benefits package

Job summary

A fast-growing consumer health company in New York is seeking a Regulatory Affairs Quality Assurance Manager to lead their regulatory strategy and ensure compliance for a diverse health portfolio. Ideal candidates have 3–5+ years of experience in Regulatory Affairs, particularly with medical devices and consumer health products. You will collaborate with R&D, Marketing, and Legal to drive compliant product launches. This role offers competitive compensation and a dynamic entrepreneurial environment.

Qualifications

• 3–5+ years’ Regulatory Affairs experience in medical devices or consumer health.
• Hands-on experience with 510(k) submissions and labeling compliance.
• Strong understanding of FDA and FTC regulations.

Responsibilities

• Lead regulatory strategy for U.S. and international markets.
• Prepare, submit, and maintain 510(k)s and global registrations.
• Monitor and advise on FDA and global regulatory changes.

Skills

Regulatory strategy

Labeling compliance

FDA regulations

Excellent communication

Cross-functional partnering

Education

Bachelor’s in Life Sciences, Chemistry, Engineering

Tools

510(k) submissions

Regulatory databases

Quality Management System (QMS)

Job description

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.