527 fda jobs at 229 companies in East Orange, NJ
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
3mo
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Director, Manufacturing Quality, GIS (Japan Based) (Center Valley, PA, US, 18034-0610)
Center Valley or Aizu
$135k-$189k/yr OnsiteFull Time
10+ YOE10+ years quality experience in regulated environment; FDA QSR/ISO 13485 knowledge; ASQ preferred; must relocate for Japan assignment.
FDA QSR, ISO 13485, MDR, CAPA, DHF, DMR, DHR
5d
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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
5d
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Senior Manager, Quality Compliance
East Windsor, New Jersey, United States
$154k-$175k/yr OnsiteFull Time
10+ YOEBachelor’s degree in a scientific discipline and 10+ years of relevant quality compliance experience with leadership responsibility, FDA inspections, GxP systems, audits, vendor oversight, and pharmacovigilance compliance.
FDA, GxP, cGMP, CAPA, SDEAs, DSCSA, SOPs, Computer, telephone
1w
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Study Director
South Brunswick Township or Dayton
$70k-$100k/yr OnsiteFull Time
5+ YOEBachelor's degree in a related field, 5+ years overseeing biocompatibility studies, knowledge of EPA, FDA, DOT, OECD, GLP, and ISO regulations, leadership, administration, communication, and writing skills.
EPA, FDA, DOT, OECD, GLP, ISO
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
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
6d
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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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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
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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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
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
1w
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Value Stream Manager (HKP)
Hackettstown, New Jersey, United States
$119k-$164k/yr OnsiteFull Time
6+ YOE5+ MgmtBachelor's degree or equivalent experience, 6+ years in a related role, 5+ years leading teams, manufacturing expertise, lean methods, HACCP, FDA and OSHA requirements, and strong communication skills.
Mars Work Systems, HACCP, FDA, OSHA
4d
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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
2mo
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Associate Director, Regulatory Affairs - Biosimilars (US)
Princeton, New Jersey, United States
$146k-$279k/yr HybridFull Time
7+ YOEBachelor's degree in life sciences and 7+ years of biopharmaceutical regulatory affairs experience, including US biosimilar programs, 351(k) BLA submissions, FDA interactions, and cross-functional leadership.
IND, BLA, FDA, Biosimilar Product Development (BPD), 351(k)
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
6d
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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
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