151 fda jobs at 62 companies in Lafayette, CO
2w
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FDA Laboratory Technician full time
Denver, Colorado, United States
OnsiteFull Time
Supports media and glassware preparation, autoclaving and MPW handling per USP/EPA/OSHA/FDA; ability to prepare media and bulk solutions; favorable Tier 2/Public Trust background investigation required.
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
1d
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Research Pharmacist
Denver or Castle Rock
$57-$107/hr OnsiteFull Time
Required: BS Pharmacy, licensed pharmacist credential, and pharmacy practice experience. Preferred: PharmD, biomedical research knowledge, USP 797, FDA guidelines, GMP, and specialized clinical training.
USP 797, FDA, Good Manufacturing Practices (GMP)
2mo
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Director of Quality Engineering
Centennial, Colorado, United States
$140k-$170k/yr HybridFull Time
Leadership in quality engineering for medical device/Class I products; QMS ownership; FDA and ISO 13485 regulatory oversight; process improvement (Lean/Six Sigma); drive defect prevention and audit readiness.
Lean/Six Sigma, Quality Management System (QMS), ISO 13485, FDA
1mo
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Production Technician - Golden (CO)
Golden, Colorado, United States
$19-$22/hr OnsiteFull Time
Perform compounding, in-process sampling/testing, equipment operation, and manufacturing paperwork while following GMP/SOP to meet FDA, USP, cGMP and cGDP standards.
blenders, tablet presses, tablet Deduster, scales, hardness testers, metal detector, tablet counter, capsule making equipment, magnifying lenses, mixer, hot plates, Microsoft Word, Microsoft Excel
1w
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Senior Quality Control Specialist
Boulder, Colorado, United States
$128k-$155k/yr OnsiteFull Time
4+ YOE4+ years QC experience in biotech/pharma (GMP) with ability to perform analytical methods, interpret stability data, and follow FDA/ICH cGMP requirements.
IP-RP-UPLC, SAX-HPLC, GC, Mass Spec, FTIR, UV
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.
2d
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Regulatory Affairs Specialist II
Lone Tree, Colorado, United States
$90k-$95k/yr HybridFull Time
1+ YOEBachelor's degree or equivalent experience, 1-3 years in regulatory affairs, technical writing skills, FDA and Health Canada knowledge; RAPS certification preferred.
3w
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QA Lab Technician - Englewood, CO
Englewood, Colorado, United States
$24-$30/hr OnsiteFull Time
Perform laboratory and QA testing of sterilization indicators, operate lab equipment, document results, maintain quality records, and follow FDA/ISO procedures in a regulated environment.
Microsoft Word, Microsoft Excel, Microsoft Outlook
1mo
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Manufacturing Supervisor - Nights
Frederick, Colorado, United States
$107k-$168k/yr OnsiteFull Time
1+ YOE1+ MgmtBachelor's degree or equivalent plus supervisory experience in FDA-regulated GMP; CQV experience, SOP/Change Control/CAPA experience, emergency response training preferred.
2mo
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Associate Director of Quality
Englewood, Colorado, United States
$130k-$160k/yr OnsiteFull Time
5+ YOE3+ MgmtLead quality assurance in a 503B facility; 5+ years QA; 3+ years leadership; US FDA cGMPs experience; bachelor's in related field; strong leadership and documentation.
Microsoft 365, Excel, Outlook
4w
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Operations Technician
Golden, Colorado, United States
$25-$27/hr OnsiteFull Time
2+ YOE2+ years manufacturing/inspection experience preferred, FDA/ISO 13485 familiarity, electronics and test equipment experience, strong attention to detail, computer skills, English proficiency.
3w
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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.
1mo
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Key Account Principal Clinical Specialist
Denver or United States
$87k-$173k/yr RemoteFull Time
3+ YOEAdvanced degree required, 3+ years EP industry experience, proficiency in Salesforce and PowerBI, willingness to travel ~50%, knowledge of FDA regulations, strong organization and multitasking skills.
Salesforce, PowerBI
3w
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Clinical Operations Manager II
Aurora, Colorado, United States
$72k-$88k/yr RemoteFull Time
4+ YOE2+ Mgmt4 years clinical research experience with 2 years project/operations management, knowledge of GCP/FDA/ICH, proficiency in Microsoft Office, strong communication and organizational skills.
Microsoft Outlook, Microsoft Word, Microsoft Excel
1mo
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Product Packaging Team Member, Bakehouse
Aurora, Colorado, United States
$19-$31/hr OnsiteFull Time
Pack products to specification, follow USDA/FDA/OSHA and facility food-safety procedures, operate packaging equipment, accurately label and document product, and lift up to 50 lbs.
box maker, shrink tunnel, metal detector, forklift, pallet jacks, hand trucks, six-wheel carts, baler
3w
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Plant Manager
Denver or Clinton Township
OnsiteFull Time
10+ YOE10+ years leadership in injection molding or advanced manufacturing, expertise in scientific molding, Lean/Six Sigma, regulated environments (ISO 13485/FDA/ITAR), automation and financial management.
RJG, Lean Manufacturing, Six Sigma
1mo
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Senior Process Development Engineer
Lakewood, Colorado, United States
$89k-$111k/yr OnsiteFull Time
5+ YOEBachelor's degree in engineering, 5+ years process development/manufacturing engineering experience, expertise in process optimization, regulatory compliance (GMP/FDA/ISO), and strong leadership and communication skills.
Aspen Plus, COMSOL, Minitab, MATLAB
5d
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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
1mo
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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