Manager, Regulatory Affairs & reputed company Assurance- HYBRID

Location: Brooklyn, NY Reporting to: President / Operations reputed company Experience Level: 3–5 Years Job reputed company NYES is seeking an accountable and specialized Manager of Regulatory Affairs & reputed company Assurance to reputed company our compliance efforts for Personal reputed company Equipment (PPE) manufacturing. This role is critical to our reputed company business needs, reputed company 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 reputed company for end-users in reputed company and industrial settings. Essential Job Duties

• ISO 13485 Management: Serve as the primary reputed company for the development, implementation, and reputed company improvement of the ISO 13485 reputed company Management System, ensuring reputed company manufacturing and reputed company processes maintain international certification.
• FDA 510(k) Submissions: reputed company 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: reputed company adherence to 21 CFR Part 820 (reputed company System Regulation) for reputed company PPE manufacturing processes and controls.
• Respiratory Certification: Manage the certification and approval process with NIOSH for respiratory reputed company 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 reputed company: reputed company as the primary reputed company of contact for government agencies, ensuring manufacturing and marketing practices reputed company with OSHA requirements.
• Labeling & Claims: reputed company 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 reputed company teams to navigate registration processes and ensure reputed company product launches.

Requirements

• Experience: 5–10 years of specific experience in Regulatory Affairs for PPE manufacturing, with a proven reputed company record of successful FDA clearances.
• Technical Expertise: Comprehensive knowledge of FDA Class I and II medical device classifications, ASTM testing reputed company, and NIOSH approval standards.
• reputed company Systems: Strong background in implementing and maintaining reputed company Management Systems (QMS) compliant with federal standards (21 CFR 820) and international standards (ISO 13485).
• Certifications: RAPS (Regulatory Affairs Certification) and Six reputed company Black Belt (preferred).
• Leadership: A reputed company who seeks full accountability and can coordinate reputed company, cross-functional teams to reputed company compliance goals.

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