LHH · 2 hours ago
Quality Assurance Regulatory Affairs Manager
New York, NY
Full-time
Hybrid
Mid, Senior Level
$110K/yr - $125K/yr
3+ years expLHH is seeking a Quality Assurance Regulatory Affairs Manager to ensure product quality and regulatory compliance across a portfolio of consumer packaged goods. The role involves managing regulatory activities, maintaining quality systems, and collaborating cross-functionally to support compliant product launches.
Human Resources
Responsibilities
Manage regulatory activities for U.S. and Canadian markets, ensuring compliance with applicable FDA, Health Canada, and FTC requirements
Maintain regulatory databases and systems, including GUDID, FURLS, and ITACS, ensuring accurate and timely updates
Support product clearance, regulatory documentation, and 510(k) preparation and submission as needed
Partner cross‑functionally to ensure compliant product claims and adherence to evolving regulatory standards
Support and maintain quality management systems and processes across the product lifecycle
Coordinate and/or perform product testing activities and ensure proper documentation
Maintain quality records and ensure alignment between product testing, manufacturing partners, and internal teams
Contribute to continuous improvement initiatives and help enhance quality reliability
Communicate effectively with internal stakeholders including R&D, Operations, Marketing, and leadership teams
Help drive clarity and alignment across project teams to support compliant and timely product launches
Qualification
Required
Bachelor's degree in Life Sciences, Chemistry, Engineering, or related field
3–5+ years of experience in Quality Assurance and/or Regulatory Affairs within medical devices, personal care, consumer health, or similar regulated categories
Strong working knowledge of applicable FDA, Health Canada, and FTC regulations
Hands‑on experience with: GUDID & FURLS database maintenance, ITACS, Product testing & clearance, Quality management systems
Regulatory documentation, including 510(k) submission preparation
Ability to operate effectively in a lean, entrepreneurial, fast‑growth environment
Excellent written and verbal communication skills, with proven cross‑functional partnership abilities
Benefits
Comprehensive benefits package (medical, vision, dental, 401k)
Company
LHH
At LHH, we believe work should be meaningful, fulfilling, and connected.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Dave Hilbig
President & CEO, OCM-LHH Utah, Wyoming
Ted Diven, MBA
CEO - OCM / Lee Hecht Harrison (ID, MT, NV)
Recent News
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2025-05-17
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