Regulatory QA Manager - Fast-Growth Consumer Health

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

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.