135 fda jobs at 54 companies in West Haven, CT
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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
1w
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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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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
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
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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.
2mo
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Compounding Inspector
New London, Connecticut, United States
$18-$20/hr OnsiteFull Time
High school diploma; ability to work 3rd shift; knowledge of cGMP/FDA/GLP; basic lab skills; English proficiency; strong record-keeping.
1mo
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Product Development Manager (5703)
Windsor Locks, Connecticut, United States
OnsiteFull Time
Lead product development for medical films and nonwovens, oversee design transfers, manage projects and trials, understand film chemistry and FDA/ISO awareness, and travel as needed.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, Microsoft Teams
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
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.
3mo
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Sr. Manager, Quality Excellence
Hauppauge, New York, United States
$155k-$175k/yr OnsiteFull Time
7+ YOE5+ MgmtExtensive leadership in Quality, QA/QC, and manufacturing operations in FDA/EPA-regulated environments; ISO 9001/13485; Lean and Six Sigma; strong governance and QMS experience.
SAP, Oracle, Veeva, Magic
3w
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Scientist II; Analytical R&D
Hauppauge, New York, United States
$70k-$90k/yr OnsiteFull Time
1+ YOEBachelor's or advanced degree in chemistry/analytical chemistry with pharmaceutical experience (1–7 years depending on degree). Knowledge of USP/FDA, method development/validation, and instrumentation required.
HPLC, UPLC, ICP, GC, FT-IR, UV, Dissolution, pH, TOC, Karl Fischer, Empower 1-3, EZ Chrome Elite, WindLab, ChemStation, Microsoft Word, Microsoft Excel, Microsoft Outlook
6d
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Quality & Compliance Manager
Doylestown or New Britain or Exeter or Seabrook
OnsiteFull Time
5+ YOERequires 5+ years in senior medical device or pharmaceutical quality assurance, FDA or Notified Body inspection experience, people management, Microsoft Office proficiency, and fluent English.
Microsoft Office
1mo
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Regulatory Affairs / Food Labeling
Hicksville, New York, United States
$70k-$90k/yr OnsiteFull Time
3+ YOEBachelors in food science/nutrition or related field, 3+ years food regulatory/labeling experience, knowledge of FDA (21 CFR) and CFIA, familiarity with QMS and controlled documentation.
ESHA Genesis R&D, Trustwell, Oracle, Microsoft Excel, Microsoft Word, SharePoint, Microsoft Teams
6d
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Senior QA Inspector
Southington, Connecticut, United States
OnsiteFull Time
2+ YOEHigh school diploma or GED, 2+ years in FDA-regulated manufacturing, strong math and records-filing skills, computer proficiency, and ability to lift up to 20 pounds.
iFactory, Oracle, Oracle Installed Base, email
3w
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INGENYX- Sr. Engineer, Development
Mansfield or Coventry or Nuevo Laredo
$146k-$219k/yr OnsiteFull Time
6+ YOE2+ MgmtBachelor's degree in engineering or a related technical field, 6+ years in medical devices or a related field, 6+ years leading projects, and knowledge of FDA GMP and ISO requirements.
Microsoft Office, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Project, EPIC Medtech, FMEA, DFMEA, Lean, 6σ
3d
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Director, Commercial REMS Operations - Pharmaceutical
Boston or New Haven
$216k-$260k/yr HybridFull Time
7+ YOEBachelor’s degree and 7+ years supporting pharmaceutical or biotechnology REMS programs, including commercial FDA REMS experience, cross-functional governance, analytics, vendor management, and executive communication.
Snowflake, SQL, Python, R
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