459 fda jobs at 206 companies in New Rochelle, NY
1d
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Healthcare & FDA Regulatory Law Specialist
New York, New York, United States
$100-$200/hr RemoteContract, Temporary
3+ YOEJ.D. and U.S. bar admission required, with 3+ years of U.S. healthcare law, FDA regulatory, or healthcare compliance practice and expertise in HIPAA, fraud and abuse laws, and FDA regulations.
ChatGPT, CMS, FDA, 510(k), PMA, NDA, LLM
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
6d
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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
3mo
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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
4d
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PM Bakery Production Team Member - NY Bakery
Elmsford, New York, United States
$21-$25/hr OnsiteFull Time
Prepare bakery ingredients, scale recipes, shape dough, build and decorate pastries, maintain FDA sanitation standards, communicate well, and lift up to 50 pounds. Training is available.
FDA, Employee Assistance Program (EAP)
5d
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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
1d
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Supplier Quality Engineer II
Trumbull or Livingston
$80k-$100k/yr OnsiteFull Time
3+ YOERequires 3+ years in regulated quality and supplier management processes, a relevant bachelor's degree or equivalent experience, and knowledge of FDA QSR, ISO 13485, supplier audits, validation, and quality systems.
FDA QSR, ISO 13485, EUMDR, ISO 14971, Change Control Systems, GD&T, Design Control, Microsoft Office, Minitab, ERP, QMS, SCAR, CAPA, NCR, NCMR, IQ, OQ, PQ, PPAP
1w
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Associate Process Engineer - Night Shift
Piscataway, New Jersey, United States
$65k-$80k/yr OnsiteFull Time
1+ YOEBachelor's degree in engineering, pharmaceutics, industrial pharmacy, or related field; 1+ year of relevant experience; process validation, manufacturing, statistical analysis, SOP, RCA, CAPA, FDA, and cGMP knowledge.
SOPs, CAPA, FDA, cGMP, RCA
1w
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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
5d
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Quality & Regulatory Affairs Lead
North Brunswick, New Jersey, United States
OnsiteFull Time
5+ YOEBachelor's degree in a scientific discipline and 5–8+ years in regulatory affairs or quality systems within biotechnology, diagnostics, medical devices, or regulated life sciences; FDA and QMS experience required.
Quality Management System (QMS), Standard Operating Procedures (SOP), Corrective and Preventive Actions (CAPA), FDA, CLIA, CAP, ISO 13485, Laboratory-Developed Tests (LDTs), In Vitro Diagnostics (IVDs), Coursera
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
4w
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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
1d
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Quality Assurance Specialist II
Union, New Jersey, United States
$65k-$80k/yr OnsiteFull Time
3+ YOEBachelor’s degree in a relevant field, 3+ years in quality assurance, leadership or audit experience, clinical monitoring experience, and knowledge of GCP, GDP, GLP, ICH E6, ISO, and FDA standards.
ISO 19011, Good Clinical Practices (GCP), International Council for Harmonisation (ICH) E6, Food and Drug Administration (FDA), GCP, GDP, GLP, ISO, FDA, ICH, KPIs
1w
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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
2w
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Group Account Supervisor
Cedar Knolls or New Jersey
HybridFull Time
4+ YOEBachelor's degree and 4–7 years of pharmaceutical advertising agency experience, including client management, project execution, MLR review, FDA regulations, brand operations, digital advertising, and multichannel strategy.
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
4d
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Sr. Director, Regulatory Affairs
Jersey City, New Jersey, United States
$235k-$289k/yr HybridFull Time
12+ YOEPostgraduate degree plus 12+ years or bachelor's degree plus 15+ years of relevant experience; in-depth FDA and international regulatory knowledge; communication, negotiation, project management, analytical, and problem-solving skills.
FDA, Investigational New Drug (IND), New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), Good Clinical Practices (GCP), Good Laboratory Practices
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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PR Consultant
New York City, New York, United States
$3k/mo RemotePart Time
3+ YOERequires 3–5+ years of consumer PR experience, an earned-media portfolio, wellness or beauty press relationships, personalized pitch writing, editorial planning, founder byline development, and FDA/DSHEA claim knowledge.
FDA, DSHEA
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