187 fda jobs at 81 companies in Bridgeport, CT
6d
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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
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
6d
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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
6d
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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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QC Manager
Plainville, Connecticut, United States
$110k-$125k/yr OnsiteFull Time
5+ YOE5+ MgmtPreferred bachelor's degree in life sciences, biology, chemistry, or related field; 5+ years of progressive laboratory management experience in pharmaceutical or GMP settings; knowledge of cGMP, USP, FDA, and ICH guidelines.
GxP, ILT, SOPs, WINs, CAPAs, FDA, Health Canada, USP, ICH, cGMP, pH meter, UV/vis spectrophotometer
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)
16h
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Lab Analyst
Melville, New York, United States
$23-$25/hr OnsiteFull Time
2+ YOEBachelor's degree in biology, biochemistry, chemistry, or related science; 2+ years in commercial food-testing or analytical laboratories; aseptic sampling, automated equipment, GLP, OSHA, FDA, BAM, APHA, ISO, and USP knowledge.
computer keyboard, mouse, automated lab equipment, GLP, OSHA, FDA, BAM, APHA, ISO, USP
5d
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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
6d
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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
1w
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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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Quality Management System (QMS) Engineer
Torrington, Connecticut, United States
$70k-$100k/yr OnsiteFull Time
3+ YOELead and maintain QMS, CAPA, NCR, audits; ensure FDA/ISO compliance in regulated medical device manufacturing.
eQMS, CAPA system, document control software
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.
4w
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Principal Microbiologist
Stamford or Trumbull
$110k-$120k/yr OnsiteFull Time
10+ YOE10+ years industry microbiology experience with preservation, antibacterial product development, regulatory interpretation (FDA), complex study design, manufacturing microbiology, and leadership.
3w
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Manager, Regulatory Affairs Strategy - Oncology
Tarrytown or Warren
$129k-$210k/yr HybridFull Time
2+ YOEDoctorate (MD/PhD/PharmD) and 2+ years regulatory experience; experience with INDs/CTAs, agency interactions, filings, and knowledge of US FDA and international regulations.
4d
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Packaging Supervisor
Ridgefield, New Jersey, United States
OnsiteFull Time
2+ YOE2+ MgmtRequires 2-5 years of manufacturing experience, Spanish-English bilingual ability, and experience supervising production teams. FDA experience and a college degree are preferred.
Standard Operating Procedures (SOPs)
3w
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QA Sr. Specialist - CAPA
Shirley, New York, United States
$80k-$95k/yr OnsiteFull Time
5+ YOEBachelor's in science/engineering,5+ years QA experience in regulated environment,knowledge of FDA regulations,CAPA writing and risk management,strong analytical and organizational skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
1w
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Senior Professional Regulatory Affairs - Lifecycle Management - Medicines
Bronx, New York, United States
HybridFull Time
5+ YOE5+ years regulatory affairs experience with lifecycle management, FDA interactions, leading complex post-approval changes, and coaching peers; scientific/technical degree preferred.
4d
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Packaging Supervisor
Ridgefield, New Jersey, United States
OnsiteFull Time
2+ YOE2+ MgmtRequires 2–5 years in manufacturing, with leadership experience preferred. Spanish bilingual ability is required; FDA experience, college graduation, and industry-standard credentials are preferred.
Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP)
3w
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Manager, Regulatory Affairs Strategy - Oncology
Tarrytown or Warren
$129k-$210k/yr HybridFull Time
2+ YOEDoctorate (MD/PhD/PharmD) and 2+ years regulatory experience; knowledge of US FDA and international guidance; experience with filings, agency interactions, and CRO engagement preferred.
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