Regulatory Affairs & Quality Assurance Associate

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NYES

Quality Assurance, Compliance / Regulatory

NYES is looking for a motivated, detail-oriented Regulatory Affairs & Quality Assurance Associate to join our team in a high-growth role. This position is specifically designed for a professional early in their career who aims to become a future leader in PPE compliance.

You will work directly under our Manager of RA/QA, serving as their “right hand” while learning the complexities of FDA, NIOSH, and ISO standards. Your primary goal is to support current compliance efforts while being mentored to eventually take full accountability for the department. This is a unique opportunity to apply your education to real-world 510(k) submissions and QMS management.

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

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

• 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. We are looking for the person who will eventually run this department.
• Impact:
  Your work ensures that frontline healthcare workers receive PPE that is safe, cleared, and effective.
• Location: Brooklyn, NY
• Level: Entry-Level (1–2 Years Experience)
• Reports To: Quality Director, Regulatory Affairs & Quality Assurance Manager

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin.

Include “Regulatory Affairs & Quality Assurance Associate” in the subject line of your email.

Applications without this will not be reviewed.