145 fda jobs at 64 companies in Castle Rock, 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.
2mo
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Director, Quality & Regulatory- Mergers & Acquisitions (M&A)
Colorado Springs or Nashville or Bothell or Gainesville or San Diego or Plymouth or Cambridge
$162k-$258k/yr HybridFull Time
15+ YOE15+ years in FDA-regulated medical device environments, leadership in quality/regulatory and M&A, Bachelor's required (Master's/MBA preferred), knowledge of FDA/ISO/EU MDR, QMS and KPI-driven governance.
QMS, FDA, ISO 13485, ISO 14971, EU MDR, TSLA, KPI
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
3d
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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
2d
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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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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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Director of Operations
Colorado Springs, Colorado, United States
$125k-$155k/yr OnsiteFull Time
8+ YOEBachelor's degree, 8+ years manufacturing experience, proven managerial experience, lean/Six Sigma experience, knowledge of GMP/ISO and FDA quality systems.
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.
4d
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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
1mo
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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.
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
2w
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Phlebotomist
Colorado Springs, Colorado, United States
OnsitePart Time
High school diploma or equivalent required; 12 months of medical or healthcare experience preferred. Must follow SOP, FDA, HSE, and OSHA requirements and operate plasma collection equipment.
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
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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