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 (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
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
1d
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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
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
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 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
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.
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.
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.