Quality Assurance & Regulatory Affairs Manager

CBIZ Talent Solutions; New York (NY); On-site; USD 140,000 - 150,000; Full time

Job summary

CBIZ Talent Solutions is seeking an experienced Quality Assurance/Regulatory Affairs Manager for a CPG client in Midtown Manhattan. The role ensures product quality, safety, and regulatory compliance across a diverse wellness portfolio while supporting product development, supplier quality, regulatory submissions, import compliance, testing, and labeling review.

The ideal candidate has 5+ years in QA/Regulatory Affairs within CPG or related industries, deep FDA/FTC knowledge, and strong

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related field.
• 5+ years of QA and/or Regulatory Affairs experience within CPG, personal care, consumer health, or similar industries.
• Strong knowledge of FDA, FTC, and consumer product regulations.
• Experience with import compliance, supplier quality management, product testing, and regulatory documentation.
• Excellent communication skills and ability to thrive in a fast-paced, entrepreneurial environment.
• ISO 13485 Lead Auditor certification, preferred.
• Regulatory Affairs Certification (RAC) or advanced degree.
• Experience with medical devices, cosmetics, OTC products, or sexual wellness categories.
• Knowledge of claims substantiation, e-commerce compliance, and marketing regulations.

Responsibilities

• Manage import documentation and compliance with CBP and FDA requirements.
• Maintain and improve the Quality Management System (QMS).
• Oversee supplier and co-manufacturer quality programs, audits, and corrective actions.
• Lead product testing, stability programs, complaint investigations, CAPA, and recall readiness.
• Provide quality training and support across the company.
• Ensure compliance with FDA, FTC, and applicable Canadian regulations.
• Manage product registrations, technical documentation, and market-entry requirements.
• Review product labeling, packaging, and marketing claims for compliance.
• Monitor regulatory changes and advise leadership on potential impacts.
• Partner with R&D, Marketing, Supply Chain, and Legal to support compliant product launches.

Skills

Quality Assurance

Regulatory Affairs

FDA/FTC knowledge

Communication

Education

Bachelor’s degree in Life Sciences

ISO 13485 Lead Auditor

RAC certification

Job description

CBIZ Talent Solutions is seeking an experienced Quality Assurance/Regulatory Affairs Manager for our CPG client in Midtown Manhattan. The QA/RA Manager is responsible for ensuring product quality, safety, and regulatory compliance across a growing, wellness product portfolio. This hands‑on role supports product development, supplier quality, regulatory submissions, import compliance, product testing, and labeling review while enabling innovation and speed to market.

Responsibilities

• Manage import documentation and compliance with CBP and FDA requirements.
• Maintain and improve the Quality Management System (QMS).
• Oversee supplier and co‑manufacturer quality programs, audits, and corrective actions.
• Lead product testing, stability programs, complaint investigations, CAPA, and recall readiness.
• Provide quality training and support across the company.
• Ensure compliance with FDA, FTC, and applicable Canadian regulations.
• Manage product registrations, technical documentation, and market‑entry requirements.
• Review product labeling, packaging, and marketing claims for compliance.
• Monitor regulatory changes and advise leadership on potential impacts.
• Partner with R&D, Marketing, Supply Chain, and Legal to support compliant product launches.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related field.
• 5+ years of QA and/or Regulatory Affairs experience within CPG, personal care, consumer health, or similar industries.
• Strong knowledge of FDA, FTC, and consumer product regulations.
• Experience with import compliance, supplier quality management, product testing, and regulatory documentation.
• Excellent communication skills and ability to thrive in a fast‑paced, entrepreneurial environment.
• ISO 13485 Lead Auditor certification, preferred.
• Regulatory Affairs Certification (RAC) or advanced degree.
• Experience with medical devices, cosmetics, OTC products, or sexual wellness categories.
• Knowledge of claims substantiation, e‑commerce compliance, and marketing regulations.

Compensation range: $140-150K/year

CBIZ Talent & Compensation Solutions is an Equal Opportunity Employer.

CBIZ Talent & Compensation Solutions does not discriminate on the basis of race, ancestry, national origin, color, religion, sex, gender identity, age, marital status, sexual orientation, disability, veteran status, or any other protected classification under the law.