427 fda jobs at 205 companies in Manhattan, NY
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Healthcare & FDA Regulatory Law Expert
New York City, New York, United States
$100-$200/hr RemoteContract, Part Time
3+ YOEJ.D. and bar admission,3+ years U.S. healthcare or FDA regulatory legal experience,knowledge of HIPAA,Anti-Kickback,Stark Law,False Claims Act,excellent written communication and attention to detail.
ChatGPT, LLM
2mo
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Director, Regulatory Advertising and Promotion (Whippany, New Jersey, US)
Whippany, New Jersey, United States
$170k-$255k/yr OnsiteFull Time
8+ YOEExtensive knowledge of US FDA regulations for prescription drug advertising; experience leading OPDP submissions; strong analytical, regulatory, and cross-functional collaboration.
FDA, OPDP, Regulatory Affairs, Promotional Review
2mo
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Quality Systems Manager – Medical Device Manufacturing
Fairfield, New Jersey, United States
OnsiteFull Time
10+ YOE10+ years in medical device quality systems; ISO 13485 and FDA QSR experience; manage QMS, audits, and regulatory readiness; Bachelor’s in Engineering or Quality.
Electronic QMS platforms, ISO 13485, FDA QSR, 21 CFR Part 820
13h
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Field Services Engineer II
Queens, New York, United States
$38-$50/hr HybridFull Time
1+ YOERequires engineering, technology, robotics, electronics, or equivalent training; hospital experience; relevant troubleshooting experience; driver's license, vehicle, and acceptable driving record. FDA and quality systems knowledge preferred.
Network Engineering, Robotics, FDA regulations, Quality Management Systems
1mo
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Compounder
Norwood, New Jersey, United States
$21-$25/hr OnsiteFull Time
2+ YOEHigh school diploma/GED, 2+ years fragrance or flavor compounding experience, ability to operate mixers/pumps/scales and forklifts, follow cGMP/FDA procedures, wear PPE, and work overtime as needed.
mixers, pumps, scales, forklift, GMP, cGMP, FDA
1mo
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Quality Engineer (Bridgeport, CT, US, 06610-0156)
Bridgeport, Connecticut, United States
OnsiteFull Time
3+ YOEBachelor's in engineering, 3+ years quality experience with metrology/CMM, GD&T, SPC/DOE, ISO and FDA QSR knowledge, blueprint reading, statistical analysis, and ability to lead inspections and corrective actions.
CMM, optical comparators, micrometers, calipers, gage blocks, pin gages, Gage R&R, GD&T, DOE, SPC, ISO, FDA, ECNs, SCRs, Material Review Board (MRB)
1mo
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Associate Director, REMS Operations (68770)
Parsippany or West Chester or United States
$159k-$194k/yr HybridFull Time
7+ YOEBachelor's degree, 7+ years program/project management in regulated industry (preferably pharma), 2+ years working with FDA, vendor management, FDA/REMS regulatory expertise, MS365 skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, MS Project, MS365, database
1mo
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Senior Manager, Regulatory Affairs - OTC
Warren, New Jersey, United States
$153k-$210k/yr HybridFull Time
7+ YOEBachelor's in pharmaceutical/life sciences required, 7+ years regulatory affairs experience (FDA/OTC/CMC), proven leadership, FDA interaction experience, strong communication and project management skills.
1mo
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Operations Supervisor
Melville, New York, United States
$60k-$80k/yr OnsiteFull Time
3+ YOELead FDA sampling operations, supervise samplers, manage scheduling, ensure FDA compliance, and coordinate with laboratory and client teams. Requires 3+ years related experience and supervisory experience preferred.
Microsoft Office
15h
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Manager - Quality
Orangeburg, New York, United States
OnsiteFull Time
5+ YOEBachelor’s degree in science or engineering, 5+ years in quality management, ISO 13485 and FDA 21 CFR 820 knowledge, lead audit qualification, and FDA inspection and certification audit experience.
Quality Management System (QMS), ISO 13485, FDA 21 CFR 820, FDA 21 CFR 210, FDA 21 CFR 211, MoCRA, ISO 14971, pFMEAs, Lean Six Sigma
1mo
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Director REMS Operations
Parsippany, New Jersey, United States
$170k-$213k/yr HybridFull Time
10+ YOEBachelor's degree, 10+ years managing large regulated programs, 5+ years working with FDA preferred, experience with REMS and vendor management, strong project management, communication, and FDA regulatory knowledge.
1mo
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Associate Director, Regulatory Affairs Advertising & Promotions
Monmouth Junction, New Jersey, United States
$180k-$225k/yr HybridFull Time
7+ YOEBachelor's in life sciences/pharmacy/medicine, minimum 7 years regulatory review experience for advertising/promotional materials in pharma/biotech, in‑depth FDA/OPDP knowledge, ability to influence, and experience preparing FDA submissions.
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Regulatory Affairs/Quality Affairs Specialist
Baldwin, New York, United States
$75k-$87k/yr OnsiteFull Time
3+ YOEBachelor's in biomedical/RA/QA or related,3+ years FDA-regulated medical device experience,510(k) and post-market/CAPA experience,RAC preferred,audit and FDA/EU/ISO13485 knowledge,strong communication and PC skills.
1mo
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Manager, Regulatory Affairs
Edison or United States or Canada or Australia
$99k-$125k/yr RemoteFull Time
7+ YOE5+ MgmtBachelor's in science or equivalent, 7+ years experience, 5+ years managerial experience, 5+ years in human tissue or medical device manufacturing, strong knowledge of FDA/QSR/cGMP/ISO, experience with FDA inspections and regulatory submissions; up to 20% travel.
2mo
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Associate Director, Regulatory Affairs - Biosimilars (US)
Princeton, New Jersey, United States
$146k-$279k/yr HybridFull Time
7+ YOE7+ years regulatory affairs in biopharma with US biosimilar experience; FDA submissions; strong cross-functional leadership and communication.
2mo
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Research Coordinator
New York, New York, United States
HybridFull Time
2+ YOEBachelor’s degree required; 2+ years in clinical research; certifications preferred; REDCap/EHR experience; HIPAA/FDA knowledge.
REDCap, EPIC, IRB Management Platforms, CTMS SMART
1mo
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Regional Regulatory Affairs Lead, US
New York, New York, United States
$191k-$234k/yr HybridFull Time
8+ YOE8+ years in medical device regulatory affairs with 5+ years on FDA-regulated devices; accountable lead on 510(k)/De Novo/PMA; direct FDA engagement; able to hold US Agent/Initial Importer/Distributor roles; experience building RA processes and teams; degree required; experience using AI for regulatory workflows.
2mo
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Director, Regulatory Affairs
Jersey City, New Jersey, United States
$213k-$233k/yr HybridFull Time
10+ YOE10+ years regulatory affairs experience; FDA and international regulatory knowledge; clinical regulatory content and submissions; strong communication; individual contributor.
eCTD, Regulatory submissions
2mo
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Foreign Medical Graduate (FMG)
Jersey City, New Jersey, United States
OnsiteFull Time
5+ YOEFMG with at least 5 years of clinical research experience; supervisory experience preferred; proficient in ICH-GCP, FDA regulations, and study conduct.
EDC, IVRS
2mo
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Quality Assurance Supervisor- New York City
Long Island City, New York, United States
$70k-$85k/yr OnsiteFull Time
5+ YOE1+ MgmtBachelor's required; 5+ years QA in cosmetics/pharma; prior QA leadership; strong FDA/cGMP and cosmetic/OTC compliance knowledge.
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