177 fda jobs at 76 companies in Maryland
1d
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Project Manager - FDA
Columbia, Maryland, United States
RemoteFull Time
Requires IT project management experience, CDISC and FDA study-data knowledge, ability to obtain High-Risk Public Trust, and unrestricted US work authorization without sponsorship.
AI/ML, Agile DevSecOps, cloud services, robotic process automation (RPA), CDISC, SDTM, ADaM, SEND, ISS, FDA EPLC
2mo
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Surgical Oncologist - FDA
Bethesda, Maryland, United States
RemoteContract
10+ YOEMD with active unrestricted U.S. medical license, 10+ years clinical experience, U.S. surgical board certification, expertise in surgical oncology devices, familiarity with FDA device regulation preferred, and strong communication skills.
electrosurgical units, ultrasonic scalpels, argon beam coagulators, robotic-assisted surgery systems, laparoscopes, thoracoscopes, tumor localization seeds, intraoperative ultrasound, radiofrequency ablation, microwave ablation, cryoablation systems, irreversible electroporation, gamma probes, near-infrared fluorescence imaging, hyperthermic intraperitoneal chemotherapy pumps, intraoperative radiation therapy systems
3mo
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Health IT Program Director (FDA Programs)
Rockville, Maryland, United States
OnsiteFull Time
15+ YOE8+ Mgmt15+ years IT program management; 8+ years leading large teams; FDA-regulated, federal contracting experience; PMP; BS in engineering; Agile.
1w
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Clinical Data Scientist, FDA (Mid)
Silver Spring, Maryland, United States
$95k-$125k/yr OnsiteFull Time
3+ YOEPhD or PharmD and 3+ years of experience required. Requires R, clinical safety data analysis, CDISC standards, statistical methods, reporting, and strong organizational and communication skills.
R, CDISC, SDTM, ADaM, Microsoft PowerPoint, Microsoft Word, Microsoft Excel, Adobe Acrobat, SharePoint, JReview, JMP, JMP Clinical, SAS
1mo
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FDA Shipping Assistant Manager Federal (must be US citizen) College Park, MD
College Park, Maryland, United States
OnsiteFull Time
1+ YOE1+ year shipping dangerous goods experience, DOT and IATA dangerous goods training, valid driver’s license; CDL with hazmat endorsement for hazardous transports; favorable background suitable for PIV/Public Trust.
1w
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Manager, Quality Assurance
Rockville, Maryland, United States
$117k-$178k/yr OnsiteFull Time
8+ YOE2+ MgmtBachelor's degree in life sciences or engineering, 8+ years in supplier quality and internal auditing in ISO or FDA QSR environments, 2 years of management experience, and FDA or ISO auditor experience required.
ISO 13485, ISO 9001, FDA QSR, MS Office Suite, Standard Operating Procedures (SOPs), Corrective and Preventive Actions (CAPA)
2d
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Quality Assurance Specialist 3
Rockville, Maryland, United States
$71k-$106k/yr OnsiteFull Time
4+ YOEBachelor's degree in biology, chemistry, engineering, or another scientific field plus 4+ years of quality assurance experience in a GxP environment. Knowledge of FDA and EU regulations preferred.
Standard Operating Procedures (SOPs), GMP, GxP, FDA, EU regulations, cGMP, GLP, CAPA, OOS
1mo
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Corporate Food Safety Manager
Baltimore, Maryland, United States
$75k-$85k/yr OnsiteFull Time
Experience in food or beverage manufacturing with strong knowledge of HACCP, GMP/CGMP, ISO 9001, FDA regulations, quality audits, CAPA, Six Sigma and Lean; training and project management experience.
HACCP, GMP, CGMP, ISO 9001, FDA, Six Sigma, Lean, GD&T, GxP
5d
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Quality Specialist 3
Rockville, Maryland, United States
$71k-$106k/yr OnsiteFull Time
4+ YOEBachelor's degree in a scientific field and 4+ years of quality assurance experience in a GxP environment; knowledge of regulated documentation, audits, CAPA, FDA and EU regulations, cGMP, GLP, and data integrity.
CAPA, GxP, SOP, FDA, EU, cGMP, GLP
2mo
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Clinical Research Coordinator III
Silver Spring, Maryland, United States
OnsiteFull Time
4+ YOERN licensed in Maryland; BLS; ACRP or SoCRA certification; 4 years clinical trials; 5 years clinical research coordination; FDA-regulated trials experience; data management and monitoring skills.
REDCap, Inform, CRFs, SOPs, GCP, GLP, FDA regulations, ICH guidelines
3d
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Senior Electrical Engineer
Hunt Valley, Maryland, United States
$151k-$153k/yr OnsiteFull Time
5+ YOEBachelor's degree and 5 years of related experience, or master's degree and 2 years. Requires PLC programming, vision systems, electrical controls, CAD, automation integration, validation, Six Sigma, Kaizen, NFPA 79, FDA, and ISO experience.
Allen Bradley, Siemens, PLC, CAD, Six Sigma, Kaizen, DOE, NFPA79, FDA, ISO
2w
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Senior Regulatory Affairs Scientist
Fort Detrick, Maryland, United States
OnsiteFull Time
12+ YOEMaster's degree and RAC required; 12+ years FDA regulatory affairs experience including INDs, NDAs, BLAs, IDEs, 510(k); experience leading FDA interactions and mentoring staff.
2mo
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Clinical Research Site Director
Baltimore, Maryland, United States
OnsiteFull Time
8+ YOE5+ Mgmt8+ years in clinical research; 5+ years managing multiple trials; experience managing teams; knowledge of FDA regulations and GCP.
EDC, IVRS
2mo
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Clinical Trial Coordinator
Bethesda, Maryland, United States
HybridFull Time
Coordinate clinical trial activities, ensure FDA/IRB compliance, document procedures, train staff, and support NIH/NLM projects.
Electronic Lab Notebook, NIH systems, POTS
1mo
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Auditor
Rockville, Maryland, United States
$100k-$133k/yr OnsiteFull Time
Bachelor's in a scientific discipline, experience in cGMP-regulated environments, strong auditing and CAPA management skills, familiarity with FDA/global regulatory expectations.
1mo
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BWI - Baltimore, MD - Utility Worker Porter
Baltimore, Maryland, United States
$16/hr OnsiteFull Time
Perform sweeping, cleaning, trash removal, and maintain sanitation per USDA/FDA/HACCP; work with cleaning agents; flexible for nights, weekends, and holidays.
3w
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Clinical Research Coordinator (52088)
Bethesda or Herndon
$90k-$140k/yr OnsiteFull Time
Bachelor's in a related field, experience with EMR/CTMS/EDC, oncology clinical trial experience, knowledge of FDA/ICH-GCP, strong organizational and communication skills.
Electronic Medical Records (EMR), clinical trial management systems, electronic data capture platforms
2w
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Research Safety Reporting Specialist (DOM Infectious Disease)
Baltimore, Maryland, United States
$54k-$94k/yr OnsiteFull Time
3+ YOEBachelor's degree and 3+ years related clinical trials experience; knowledge of safety reporting, FDA guidelines, SOP development, regulatory compliance, and stakeholder communication.
Microsoft SharePoint, WordPress
2mo
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Clinical Research Manager
Bethesda, Maryland, United States
$105k-$120k/yr OnsiteFull Time
3+ YOE1+ MgmtBachelor's degree or experimental background; 3-5 years clinical research; 1-3 years staff/project management; FDA-regulated trials experience preferred.
Excel, Microsoft Office
4w
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Phlebotomist 1
Riverdale, Maryland, United States
OnsiteFull Time
Perform venipuncture and plasmapheresis, operate automated plasmapheresis machines, follow FDA/OSHA/CLIA/GMP protocols, maintain documentation, and provide high-quality donor customer service.
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