206 fda jobs at 95 companies in Leesburg, VA
2d
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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)
1d
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Warehouse Quality Coordinator
Hagerstown, Maryland, United States
$22/hr OnsiteFull Time, Temporary
High school diploma required; associate degree preferred. Requires food-grade facility experience, GMP and FDA/USDA knowledge, and strong written and verbal communication skills.
Microsoft?, Pallet Hand Jack, GMPs, FDA, USDA
3d
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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
22h
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Quality Coordinator II
Hagerstown, Maryland, United States
$22/hr OnsiteFull Time, Temporary
High school diploma required; associate's degree preferred. Requires food-grade facility experience, GMP and FDA/USDA knowledge, and strong written and verbal communication skills.
Computer, Pallet Hand Jack, Good Manufacturing Practices (GMPs), FDA, USDA
6d
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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
1d
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Warehouse Supervisor - Second Shift
Front Royal, Virginia, United States
OnsiteFull Time
5+ YOERequires 5+ years of food-industry warehousing experience, leadership capability, English and Spanish fluency, food safety knowledge including HACCP, FDA, and SQF, WMS and reporting tools, and Microsoft Office proficiency.
WMS, HACCP, FDA, SQF, Microsoft Office, Microsoft Excel
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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Director, Regulatory Affairs – Regenerative Medicine & Biologics Quality
Washington, District of Columbia, United States
$135k-$377k/yr OnsiteFull Time
5+ YOEBachelor's in scientific/engineering/regulatory required; MS/PhD preferred; 5+ years FDA-related regulatory affairs experience across human medical products; project/people management experience; knowledge of FDA, ICH, ISO; strong writing and analytical skills.
Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint
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
2mo
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Health Care Life Sciences Regulatory Associate (Mid-Level) – DC
Washington, District of Columbia, United States
$260k-$390k/yr HybridFull Time
3+ YOEThree to six years of life sciences regulatory experience; FDA regulatory knowledge; strong communication and analytical skills; bar admission required.
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.
1w
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Quality Assurance Manager
Manassas, Virginia, United States
OnsiteFull Time
6+ YOEcGMP and FDA knowledge, 6+ years QA experience in pharmaceutical manufacturing (or master's with 4+ years), strong documentation, audit, CAPA, and training skills.
Microsoft Office Suite, Adobe
3mo
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Medical Device and Technology - Junior to Mid-Level Associate
Washington, District of Columbia, United States
$235k-$310k/yr OnsiteFull Time
2+ YOEDC Bar admission; strong writing/analytical skills; FDA/medical device regulatory experience preferred; law degree from ABA-accredited school.
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
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