157 fda jobs at 68 companies in Danbury, 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
1d
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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
1d
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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
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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
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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)
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Operations Supervisor
Melville, New York, United States
$60k-$80k/yr OnsiteFull Time
3+ YOELead FDA sampling operations, supervise samplers, manage scheduling, ensure FDA compliance, and coordinate with laboratory and client teams. Requires 3+ years related experience and supervisory experience preferred.
Microsoft Office
1d
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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
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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
3w
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Quality System Specialist II - Document Control
Franklin Lakes, New Jersey, United States
$110k-$176k/yr OnsiteFull Time
2+ YOESupports quality systems and documentation management for engineering and product development; knowledge of FDA/ISO regulations, good documentation practices, and use of quality tools.
SAP, Docusign, PEGA, Trackwise
3w
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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.
2w
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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.
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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.
2w
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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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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
3w
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Manufacturing Supervisor- 2nd Shift
Farmingdale, New York, United States
$75k-$85k/yr OnsiteFull Time
5+ YOE5+ years manufacturing/packaging leadership (FDA/GMP preferred), supervisory and communication skills, ability to lift 50 lbs and stand long periods, flexible for additional shifts.
2mo
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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
2w
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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
2w
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Prin Regulatory Affairs Spec
North Haven or Mansfield or Mounds View or Boston or Lafayette
$120k-$180k/yr OnsiteFull Time
7+ YOEBachelor's degree and 7+ years regulatory experience (or advanced degree with 5+ years). Experience with 510(k), FDA interactions, international registrations, labeling and promotional material review.
2w
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Mammography Technologist - Bronx
Bronx or Lake Success
$73k-$89k/yr OnsiteFull Time
Northwell Health: Provides clinical healthcare services through a hospital network.
2+ YOECurrent NY radiologic technologist license, ARRT(M) certification, bachelor’s degree, minimum 2 years experience, proficiency with GE PACS and EPIC, MQSA/FDA QA knowledge.
GE PACS, EPIC
4w
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Senior Quality Specialist (Hybrid)
Bohemia, New York, United States
$85k-$100k/yr HybridFull Time
5+ YOE5+ years quality experience in manufacturing, knowledge of FDA regulations, food safety/HACCP and GMPs, project management, statistical analysis, and proficiency with Windows applications and SAP/PLM/QMS.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, SAP, Viva, PLM, QMS
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