2mo
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FDA + Healthcare Regulatory and Compliance Associate (Mid-Level)
Washington, District Of Columbia, United States
$260k-$365k/yr OnsiteFull Time
3+ YOE3–5 years of FDA practice or FDA/USDA experience; strong counseling in food, beverage, dietary supplement; ability to work independently and across teams; admitted or eligible to waive into the practicing state bar.
1mo
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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
1mo
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Senior Business Requirements Analyst - FDA
Gaithersburg or Falls Church
$124k-$155k/yr HybridFull Time
10+ YOEBachelor's degree, 10+ years business analysis experience (IT), recent FDA experience, 6+ years federal support, product ownership, Agile/SCRUM, UI/UX and data/analytics experience, familiar with JIRA/Confluence/Tableau/Power BI/SQL.
Scaled Agile Framework (SAFe), JIRA, Confluence, Tableau, Microsoft Power BI, SQL, Appian, Salesforce, Pega
1mo
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Senior Business Requirements Analyst - FDA
Gaithersburg or Silver Spring or Falls Church
$124k-$155k/yr HybridFull Time
10+ YOEBachelor's degree, 10+ years business analysis experience in IT, recent FDA experience, 6+ years supporting federal agencies, product owner/Agile expertise, UI/UX and data analytics experience, familiarity with JIRA/Confluence and Tableau/Power BI/SQL.
Scaled Agile Framework (SAFe), JIRA, Confluence, Tableau, Microsoft Power BI, SQL, Appian, Salesforce, Pega
2mo
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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.
1mo
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Clinical Data Scientist, FDA (Jr.)
Silver Spring, Maryland, United States
$90k-$120k/yr OnsiteFull Time
3+ YOE3+ years' professional experience; mandatory R programming; experience with CDISC standards (SDTM, ADaM); clinical safety data analysis and reporting; doctorate in STEM disciplines preferred; U.S. citizen or permanent resident eligible for Public Trust.
R, CDISC, SDTM, ADaM, JReview, JMP, JMP Clinical, SAS, Microsoft PowerPoint, Microsoft Word, Microsoft Excel, Adobe Acrobat, SharePoint
3mo
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Associate Director, Regulatory Affairs
Berkeley Heights or New York or Frederick or Fort Worth or Berkeley Heights
$145k-$200k/yr RemoteFull Time
7+ YOE5+ MgmtLead regulatory strategy and submissions for early to clinical development of biologics/drugs; manage regulatory documentation and interactions; ensure compliance with FDA/EU and ICH; strong leadership.
Regulatory Submissions, IND, FDA Regulations, EU Regulations, ICH Guidelines
3w
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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
1mo
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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
1mo
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Warehouse Manager
Savage, Maryland, United States
$90k-$115k/yr OnsiteFull Time
5+ YOEExperience in food manufacturing; 5+ years in warehouse/operations; knowledge of ERP systems, HACCP, SQF, USDA/FDA; 4-year degree preferred in logistics or business administration; strong leadership and communication skills.
ERP, HACCP, SQF, FDA, USDA
1mo
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Strategy Lead, CMC Mature, Regulatory Affairs
Rockville or Waltham or Cambridge or Upper Providence or San Francisco
$114k-$190k/yr HybridFull Time
2+ YOEBachelor's in life sciences/pharmacy/chemistry required; 2+ years CMC regulatory affairs experience (IND/BLA) with FDA liaison experience, eCTD Module 3, knowledge of 21 CFR, ICH, GMP/GDP, biologics CMC and lifecycle management.
eCTD Module 3, 21 CFR, ICH, GMP, GDP, IND, BLA, FDA
2w
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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
21h
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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
3mo
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Regulatory Risk & Quality Manager
Fort Detrick, Maryland, United States
OnsiteFull Time
Regulatory risk, quality management, training, audits; knowledge of FDA/ISO standards, GxP, CAPA, risk management.
2d
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Production Associate
Laurel, Maryland, United States
$17-$18/hr OnsiteFull Time
Experience in food production preferred; knowledge of FDA regulations, HACCP and CGMP, basic math, sanitation, and ability to follow procedures.
E-Verify
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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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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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.
2mo
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Senior Manager, Food Safety & Quality Assurance (BETHESDA, MD, US, 20817)
Bethesda, Maryland, United States
$100k-$121k/yr OnsiteFull Time
6+ YOE2+ MgmtLead FSQA programs, manage FDA registrations, vendor audits, and regulatory compliance; 6+ years in hospitality/food safety; ServSafe certification.
4w
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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.
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