354 fda jobs at 172 companies in Stamford, CT
22h
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Healthcare & FDA Regulatory Law Specialist
New York, New York, United States
$100-$200/hr RemoteContract
3+ YOEJ.D. and U.S. bar admission required; 3+ years of U.S. legal practice in healthcare law, FDA regulatory affairs, or healthcare compliance. Expertise in HIPAA, Anti-Kickback, Stark, False Claims, and FDA regulations.
ChatGPT, 510(k), PMA, NDA
1w
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QC Microbiologist
South Ogden or Montvale or United States or Europe
OnsiteFull Time
2+ YOEBachelor's degree in microbiology or related field, 2–4 years in a cGMP microbiology laboratory, microbiological assays, aseptic techniques, cGMP, FDA, USP, AOAC, FDA BAM, allergen testing, and ISO 17025 knowledge.
cGMP, FDA, USP, AOAC, FDA BAM, ISO 17025, MSDS, SOPs
1d
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Quality Assurance Manager Plasma Donation Center
Brooklyn, New York, United States
$75k-$85k/yr OnsiteFull Time
Bachelor's degree in a related field, quality assurance management experience in healthcare or pharmaceuticals, and knowledge of FDA, CGMP, HACCP, and ISO 13485 standards.
FDA, ISO 13485, CGMP, HACCP
2mo
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Clinical Research Coordinator 2
New Haven, Connecticut, United States
$65k-$101k/yr OnsiteFull Time
2+ YOECoordinate clinical trials; manage screening, eligibility, recruitment; ensure compliance with GCP, FDA, HIPAA; independent multi-study management; strong communication.
GCP, FDA Regulations, HIPAA, EMR, Clinical Trial Management Systems
1w
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Prin Regulatory Affairs Spec - Core Surgical innovations
Lafayette or Mansfield or Mounds View or North Haven or Boston
$120k-$180k/yr OnsiteFull Time
5+ YOEBachelor's degree and 7+ years or advanced degree and 5+ years in regulatory affairs; medical device, FDA, EU, ISO, audits, submissions, leadership, and communication experience required.
FDA, Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, artificial intelligence, machine learning
21h
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Vice President, Clinical Development – Hematology, Transplant and Cell Therapy
New York City, New York, United States
HybridFull Time
10+ YOEMD or equivalent, 10+ years of industry clinical development experience, deep hematology expertise, AML and MDS knowledge, transplant or cellular therapy experience, and FDA/global regulatory leadership.
Actimab-A, AWE, CAR-T, NK, FDA, EMA, IND, BLA, CSR, DSMB, DMC, CRO, NCI CRADA
2d
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Quality Assurance: Quality Assurance Administrative Assistant
Parsippany, New Jersey, United States
$22-$26/hr OnsiteFull Time
3+ YOEAssociate degree or 3 years of experience; knowledge of FDA, ISO 13485, and ISO 9001 regulatory processes; Microsoft Office proficiency; strong organization, multitasking, communication, and time management skills.
Microsoft Office, FDA, ISO 13485, ISO 9001
1w
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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
1w
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QA Associate Technical & Regulatory
Elgin or Fairfield or Arizona or Arkansas or California or Colorado or Connecticut or Florida or Georgia or Hawaii or Illinois or Minnesota or Nevada or New Jersey or New York or Ohio or Pennsylvania or South Carolina or Tennessee or Texas or Washington or Wyoming or Wisconsin
$28-$34/hr RemoteFull Time
Schuman Cheese: Imports, produces, and distributes specialty cheese products.
1+ YOEBachelor's degree preferred; 1–3 years in quality assurance, regulatory, or technical work in manufacturing or food production; knowledge of FDA, USDA, HACCP, GMP, or FSMA and Microsoft Office proficiency.
FDA, USDA, HACCP, GMP, FSMA, Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft Outlook
3w
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Packaging Engineer
Summit or Fort Washington
$71k-$107k/yr OnsiteFull Time
5+ YOERequires 5–7 years of professional experience; bachelor's degree in packaging engineering preferred. Experience with packaging validation, specifications, component development, skin care or cosmetics, FDA, or GMP preferred.
FDA, GMP
2d
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Associate Technical Writer (Deviation Assessment), CAR-T Manufacturing Technical Support
Summit, New Jersey, United States
OnsiteFull Time
2+ YOEKnowledge of cGMP manufacturing or quality and FDA-regulated industry practices; strong technical and compliance writing, communication, critical thinking, multitasking, and MS Office skills. Degree or equivalent manufacturing experience required.
Microsoft Office, QMS, FDA
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)
1d
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Prin Quality Engineer
Lafayette or North Haven or Boston or Minneapolis or Los Angeles County
$121k-$181k/yr OnsiteFull Time
Bachelor's degree in engineering or related technical field; in-depth FDA, ISO 13485, and ISO 14971 knowledge; quality, risk management, regulatory, statistics, root-cause analysis, leadership, and project management expertise.
FDA, ISO 13485, ISO 14971, ISO 62304, FDA Part 820, Design Failure Modes and Effects Analyses (DFMEAs), Process FMEA, User FMEA
1w
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Regulatory Coordinator
Bohemia, New York, United States
$65k-$70k/yr OnsiteFull Time
Regulatory compliance experience in an FDA-regulated industry; knowledge of DSHEA, CFR, and FDA labeling guidance; strong organization, communication, documentation, and Microsoft Office skills.
Microsoft Office Suite
1w
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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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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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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.
2w
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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.
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
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