197 fda jobs at 84 companies in Manassas, VA
1mo
Save
Mark Applied
Hide
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
Save
Mark Applied
Hide
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.
2mo
Save
Mark Applied
Hide
Clinical Data Scientist, FDA (Sr.)
Silver Spring, Maryland, United States
$100k-$135k/yr OnsiteFull Time
3+ YOEMinimum 3 years' experience; mandatory R programming; experience with CDISC (SDTM/ADaM), clinical safety analyses, MS Office and Adobe Acrobat; ability to obtain Public Trust and eligibility as US citizen or permanent resident.
R, CDISC, SDTM, ADaM, JReview, JMP, JMP Clinical, SAS, Microsoft PowerPoint, Microsoft Word, Microsoft Excel, Adobe Acrobat, SharePoint
3w
Save
Mark Applied
Hide
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.
2d
Save
Mark Applied
Hide
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)
14h
Save
Mark Applied
Hide
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
Save
Mark Applied
Hide
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
1mo
Save
Mark Applied
Hide
Director Promotional Regulatory Affairs
Gaithersburg or Wilmington
HybridFull Time
5+ YOEBachelor's in science,3+ years promotional regulatory experience,5+ years total pharma/biotech experience,knowledge of FDA OPDP/APLB and labeling,ability to lead MLR and engage with FDA.
AZAP
2w
Save
Mark Applied
Hide
Clinical Trial Manager
Fort Detrick, Maryland, United States
$125k-$143k/yr OnsiteFull Time
7+ YOEBachelor's in life sciences, 7+ years clinical trial management experience, FDA-regulated study experience, strong ICH-GCP and FDA knowledge, able to manage TMF and support inspections.
ClinicalTrials.gov
2mo
Save
Mark Applied
Hide
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
Save
Mark Applied
Hide
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
Save
Mark Applied
Hide
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.
2mo
Save
Mark Applied
Hide
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.
1w
Save
Mark Applied
Hide
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
2mo
Save
Mark Applied
Hide
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.
2w
Save
Mark Applied
Hide
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
2mo
Save
Mark Applied
Hide
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
1w
Save
Mark Applied
Hide
Clinical Research Coordinator
Washington, District of Columbia, United States
$52k-$86k/yr OnsiteFull Time
1+ YOEB.A./B.S. in a relevant field,1+ year research experience,knowledge of GCP,OHRP and FDA regulations,ability to manage study documentation,participant recruitment and specimen handling.
2mo
Save
Mark Applied
Hide
Safety Physician (CONTRACT)
Germantown, Maryland, United States
OnsiteContract
MD/MBBS; post-marketing pharmacovigilance experience; knowledge of FDA/EMA PV regs, ICH E2, signal detection, benefit-risk, MedDRA; safety databases experience.
MedDRA, PV databases, Signal detection tools
3w
Save
Mark Applied
Hide
Sr Manager, Federal Government Affairs
Washington or United States
$156k-$261k/yr RemoteFull Time
10+ YOE5+ Mgmt10+ years federal government affairs experience in healthcare/medical technology; bachelor’s required (advanced preferred); strong knowledge of Medicare/Medicaid, FDA, reimbursement, and stakeholder engagement.