Regulatory Affairs & Quality Assurance Associate

• Assist the Manager in the daily maintenance of the ISO 13485 Quality Management System, including document control and CAPA tracking
• Support the preparation of FDA 510(k) premarket notifications and NIOSH approval packets for N95 respirators and surgical masks
• Perform routine checks to ensure manufacturing processes align with 21 CFR Part 820 (Quality System Regulation)
• Draft and update Standard Operating Procedures (SOPs), labeling, and IFUs (Instructions for Use) to ensure accurate regulatory claims
• Work with third-party labs to track ASTM barrier performance testing (fluid resistance, viral penetration) and organize results for regulatory dossiers
• Participate in internal audits and assist in preparing the facility for external inspections from the FDA or Notified Bodies

• Recent Regulatory Affairs and Quality Assurance (RAQA) Graduate Program
• 1–2 years of experience in a regulated industry (MedTech, Biotech, or Pharma)
• Internship experience in RA/QA is highly valued
• Understanding of FDA Class I and II medical device classifications
• Familiarity with ISO 13485 and 21 CFR 820 frameworks
• High level of technical writing proficiency
• attention to detail
• a "student of the craft" mentality
• A clear desire to grow into a leadership role within NYES

Internship experience in RA/QA

• Direct Mentorship: Learn from a veteran Lead with 5–10 years of specialized PPE experience
• Clear Career Path: This isn’t just a job
• it’s a prepared seat
• Impact: Your work ensures that frontline healthcare workers receive PPE that is safe, cleared, and effective