Position Overview:
NYES is seeking an accountable and specialized Manager of Regulatory Affairs & Quality Assurance to lead our compliance efforts for Personal Protective Equipment (PPE) manufacturing. This role is critical to our current business needs, focused on ensuring our products meet and exceed FDA, NIOSH, and OSHA regulatory standards.
The ideal candidate will have deep, specific experience in the regulatory lifecycle of PPE, including medical-grade masks and gowns. You will have full accountability for this functional area, ensuring every product is legally cleared for sale and safe for end-users in healthcare and industrial settings.
Key Responsibilities:
- ISO 13485 Management: Serve as the primary lead for the development, implementation, and continuous improvement of the ISO 13485 Quality Management System, ensuring all manufacturing and quality processes maintain international certification.
- FDA 510(k) Submissions: Lead the preparation and submission of FDA 510(k) premarket notifications for medical-grade PPE (e.g., surgical masks, isolation gowns, etc.) to ensure products are "FDA-cleared."
- Manufacturing Compliance: Oversee adherence to 21 CFR Part 820 (Quality System Regulation) for all PPE manufacturing processes and controls.
- Respiratory Certification: Manage the certification and approval process with NIOSH for respiratory protective devices, such as N95 respirators.
- Standardization & Testing: Ensure materials meet rigorous ASTM International standards for barrier performance, including fluid resistance (ASTM F903) and viral penetration (ASTM F1671).
- Government Regulatory Liaison: Act as the primary point of contact for government agencies, ensuring manufacturing and marketing practices align with OSHA requirements.
- Labeling & Claims: Direct the development of labeling and packaging to ensure accurate regulatory claims and prevent the marketing of unverified equipment.
- Cross-Functional Support: Partner with product development and commercial teams to navigate registration processes and ensure timely product launches.
Required Qualifications:
- Experience: 5–10 years of specific experience in Regulatory Affairs for PPE manufacturing, with a proven track record of successful FDA clearances.
- Technical Expertise: Comprehensive knowledge of FDA Class I and II medical device classifications, ASTM testing methods, and NIOSH approval standards.
- Quality Systems: Strong background in implementing and maintaining Quality Management Systems (QMS) compliant with federal standards (21 CFR 820) and international standards (ISO 13485).
- Certifications: RAPS (Regulatory Affairs Certification) and Six Sigma Black Belt (preferred).
- Leadership: A professional who seeks full accountability and can coordinate complex, cross-functional teams to achieve compliance goals.
Why Join Us?
This role offers the chance to lead a distinct and meaningful functional area within our company. Your work will directly impact the safety of healthcare workers and laborers by ensuring they have access to verified, high-quality protective equipment.
Location: Brooklyn, NY
Reporting to: President
Experience Level: 5–10 Years
Compensation: Salary Commensurate with Experience and Qualifications
