64 fda jobs at 21 companies in Fort Collins, CO
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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
3d
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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
1mo
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Paramedic/EMT-P
Thornton, Colorado, United States
$28-$39/hr OnsiteFull Time
2+ YOEEMT-Paramedic license, CPR/AED certification, basic IV therapy, FDA Medical Support Specialist training, and 2 years clinical experience required.
1w
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Senior Specialist, Quality Assurance
Louisville or Seattle
$105k-$130k/yr HybridFull Time
8+ YOEBachelor's degree in life sciences or technical discipline and 8+ years in an FDA-regulated industry. Requires cGMP and quality systems expertise, risk assessment, documentation, investigation, and collaboration skills.
Fidelity
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Staff Software Engineer, Valence
Louisville, Colorado, United States
$130k-$145k/yr OnsiteFull Time
8+ YOE8+ years in surgical navigation or medical device software; proficiency in C++ on Linux, 3D geometry and imaging, image processing toolkits, experience in FDA-regulated environments, strong leadership and communication.
C++, Linux, Qt, DICOM, VTK, ITK, OpenCV, GIT, Azure DevOps
2w
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Validation Engineer
Frederick or Boulder
$82k-$129k/yr OnsiteFull Time
1+ YOEBachelor's in engineering or life sciences,1+ years relevant experience,knowledge of cGMP/FDA/ICH regulations,validation experience (IQ/OQ/PQ/SAT),CAPA and change control experience.
URS, Software Acceptance Testing (SAT), IQ, OQ, PQ, GAMP, 21 CFR, ICH, Eudralex Volume 4 Annex 15, CAPA, spreadsheets
2w
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Consultant II
Boston or San Diego or Boulder or India
RemoteFull Time
3+ YOEBachelor's in life sciences/regulatory required, 3–5 years pharma/biotech regulatory experience, promotional review expertise, strong FDA/Health Canada knowledge, project management and communication skills.
1mo
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Senior Clinical Research Associate - Cardiovascular (In-House)
Boulder, Colorado, United States
$90k-$140k/yr HybridFull Time
4+ YOEMinimum 4 years clinical operations and on-site monitoring experience, BS/BA in life sciences, cardiac study experience preferred, MS Office and Smart Sheet proficiency, knowledge of FDA/ICH/GCP.
Microsoft Office, Microsoft PowerPoint, Smart Sheet
3w
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Associate Director, Clinical Operations
Waltham or Boulder
$185k-$215k/yr HybridFull Time
6+ YOE6+ years clinical development experience, BS/BA preferred, experience leading multi‑phase trials, CRO/vendor management, GCP/ICH/FDA knowledge, SOP development, and ability to travel ~25%.
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Quality Management System Manager
Boulder, Colorado, United States
$115k-$135k/yr OnsiteFull Time
5+ YOEBS required; 5+ years in quality management in advanced manufacturing; strong knowledge of ISO standards and FDA QSR; experience with NPI, root cause analysis, CAPA, supplier quality; Six Sigma/Lean preferred.
Microsoft Office, SPC, Pareto Diagrams, Affinity Diagrams, Fault-Tree Analysis, Design of Experiments
1mo
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Sr. Supplier Quality Management Specialist
Boulder, Colorado, United States
$115k-$125k/yr OnsiteFull Time
12+ YOEBachelor's degree (or equivalent) with ~12 years' related experience in pharmaceutical/biopharma manufacturing; supplier management and external auditing experience; familiarity with cGMP/GLP/FDA guidelines; SAP, eQMS (MasterControl), and Microsoft Office experience.
SAP, MasterControl, Microsoft Office
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Validation Engineer II
Windsor, Colorado, United States
$90k-$100k/yr OnsiteFull Time
2+ YOEBachelor's in engineering or life sciences, minimum 2 years validation experience in sterile pharma, cGMP/FDA/EU knowledge, Microsoft Office proficiency, strong technical writing, project management, and aseptic/cleanroom familiarity.
Microsoft Office
1d
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FSQA Supervisor
Thornton, Colorado, United States
$28-$30/hr OnsiteFull Time
5+ YOE2+ MgmtRequires 5+ years of related food manufacturing QA experience, including 2+ years supervising or leading. Requires FDA knowledge, HACCP certification, quality systems expertise, and strong communication and decision-making skills.
2mo
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Senior Manager, Nutrition & Scientific Affairs
Louisville or White Plains
$118k-$169k/yr HybridFull Time
6+ YOERegistered Dietitian with 6+ years in nutrition science or scientific affairs, advanced degree in nutrition or related field, experience with claim substantiation, familiarity with US regulatory frameworks (FDA, FTC), strong cross-functional leadership and communication.
1mo
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Director, Quality Assurance
Louisville or Centennial
$202k-$277k/yr OnsiteFull Time
Bachelor's or equivalent, proven experience managing large teams and QA programs in regulated industries, deep knowledge of FDA/ISO/GxP, experience with product release, CAPA, change control, validation, audits, risk management, and strong communication.
eQMS
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Hardware Engineering Manager
Loveland, Colorado, United States
$125k-$150k/yr OnsiteFull Time
7+ YOE3+ MgmtBachelor's degree in engineering, 7+ years industry experience with 3+ years leading engineering teams; expertise in hardware product development, SolidWorks/CAD proficiency, familiarity with ISO/FDA regulatory compliance, and strong leadership and project management skills.
SolidWorks, CAD, DFMEA, PFMEA, Danaher Business System
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Senior Software Engineer (Loveland, CO)
Loveland, Colorado, United States
$107k-$134k/yr OnsiteFull Time
5+ YOEFive or more years in professional software development; strong C++ and embedded Linux experience; DevOps (Docker, GitLab CI); cloud infrastructure (AWS/Azure); GUI with Qt; Yocto; LIMS/EHR connectivity; regulated software (IEC 62304 FDA QSR ISO 13485).
C++, Embedded Linux, Docker, GitLab CI, AWS, Azure, Qt, Yocto
2mo
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Senior Clinical Research Associate - Cardiovascular (EDG-2026033)
Boulder or United States
$90k-$140k/yr HybridFull Time
4+ YOE4+ years clinical operations experience, BS/BA in life sciences, 4 years independent on-site monitoring, 3 years cardiac study experience preferred, MS Office and Smart Sheet proficiency, knowledge of FDA/ICH/GCP, strong communication and attention to detail.
Microsoft Office, Microsoft PowerPoint, Smart Sheet, Electronic Data Capture (EDC)
4d
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Director, Business Systems & Manufacturing Applications (25770)
Chatsworth or Carlsbad or Longmont or Westborough
$135k-$145k/yr HybridFull Time
10+ YOERequires 10+ years of manufacturing ERP, MES, or business systems leadership; multi-site experience; ERP modernization; vendor management; software development depth; people management; executive communication; and travel up to 50%.
Epicor, Aegis, Microsoft Excel, ERP, MES, BI, AI, ML, Epicor Kinetic, Epicor BPMs, BAQs, dashboards, ITAR, CUI, FDA, ISO, AS9100, LLM
3d
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Prepared Foods Team Member (Deli Service Counter & Culinary Venues) - Full Time
Boulder, Colorado, United States
$20-$30/hr OnsiteFull Time
No prior retail experience required. Must provide customer service, follow food safety procedures, lift 50 pounds, stand and walk for 6–8 hours, use kitchen and material-handling equipment, and work flexible shifts.
FDA, electric pallet jacks
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