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Technical FDA Writer
Olive Branch, Mississippi, United States
OnsiteFull Time
3+ YOEBachelor's degree,3+ years technical writing in FDA-regulated manufacturing,experience with QMS documentation (SOPs/WIs),knowledge of 21 CFR Part 820 and ISO 13485, audit support experience.
MasterControl, Veeva QualityDocs, Greenlight Guru, ETQ, Microsoft Word, Visio, Lucidchart, Microsoft 365, Teams, SharePoint, OneDrive
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 Quality Analyst – FDA Regulated Manufacturing
Rochester, Minnesota, United States
$85k-$128k/yr OnsiteFull Time
5+ YOE5+ years supporting FDA-regulated product manufacturing, quality, regulatory, or compliance; knowledge of FDA GMPs, EU regulations, ISO; audit experience; strong communication, project management, and regulatory-interpretation skills; ASQ certification encouraged.
1mo
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Senior Quality Analyst – FDA Regulated Manufacturing
Rochester, Minnesota, United States
$85k-$128k/yr OnsiteFull Time
5+ YOE5+ years supporting FDA-regulated product manufacturing, quality, regulatory, or compliance; knowledge of FDA GMPs, EU regulations, ISO; ability to interpret regulations, conduct audits, implement QMS; strong communication and project management skills.
Quality Management System (QMS)
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.
3w
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FDA Senior Analyst
Los Angeles, California, United States
$105k-$120k/yr OnsiteFull Time
2+ YOEBachelor's in Accounting/Computer Science or related, 2+ years accounting/CS experience, OneStream/D365/Alteryx/Jira/Power Query/Microsoft Excel proficiency, audit and UAT experience, strong communication and analytical skills.
OneStream, Microsoft Excel, Power Query, Alteryx, Jira, Microsoft Dynamics 365 F&O
3mo
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Underage Purchaser – FDA Tobacco Inspection Program
Central, North Carolina, United States
OnsitePart Time, Temporary
Age 18–20; valid driver’s license; ability to travel; pass NC background check; participation in FDA NC tobacco inspections.
1d
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Certified QMS Auditor (ex FDA Experience)
Pittsburgh, Pennsylvania, United States
RemoteFull Time
Certified QMS auditor with strong CAPA and quality system experience, ability to assess implementation and verification of effectiveness, remediation support, and FDA submission readiness.
1w
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Regulatory Affairs Specialist (FDA medical device regulation)
Lexington, Massachusetts, United States
RemoteFull Time
2+ YOEBachelor's degree plus 2+ years regulatory affairs experience in U.S. FDA medical device environment or RAC plus 4+ years; knowledge of FDA regulations and ISO 13485; strong communication and organizational skills.
1w
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Regulatory Affairs Specialist (FDA medical device regulation)
United States
RemoteFull Time
2+ YOEProvide regulatory support for US FDA medical device requirements, ISO 13485/MDSAP, prepare 510(k)/PMA and international submissions, handle complaints, field actions, and QMS activities.
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
4w
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Wastewater Operator/Maintenance Tech - FDA
Litchfield, Minnesota, United States
$20-$30/hr OnsiteFull Time
High school diploma or equivalent; ability to obtain wastewater certification within 1 year; clean driving record; strong mechanical skills; ability to work independently; on-call weekend/after-hours availability when scheduled.
1mo
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Senior Regulatory Affairs Specialist -FDA Medical (Ann Arbor, MI, US, 48108)
Ann Arbor, Michigan, United States
OnsiteFull Time
7+ YOE7+ years in FDA regulatory affairs; strong knowledge of 21 CFR; experience with DMF/MAF; cross-functional collaboration; leadership.
1mo
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Staff Engineer, Design Quality (CDx/FDA)
Marlborough, Massachusetts, United States
$105k-$125k/yr HybridFull Time
8+ YOESenior design quality expert with 8+ years in medical device/IVD quality, strong regulatory and technical judgment.
1mo
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FDA Supervisor, Gateway Clearance (Saturday - Wednesday, 7:00 a.m. - 3:30 p.m.)
Erlanger, Kentucky, United States
OnsiteFull Time
3+ YOE1+ MgmtManage customs clearance operations, ensure regulatory compliance, supervise ~30 staff with 2 direct reports, BS/BA and 3+ years related experience (1+ year supervisory), U.S. Customs Broker license preferred, ability to obtain SIDA badge.
2mo
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Regulatory Affairs Professional/Sr. Regulatory Affairs Professional
Grand Rapids, Michigan, United States
OnsiteFull Time
10+ YOEBachelor’s in Life Sciences; 10+ years pharma experience; 6+ years regulatory affairs; FDA/ICH/good manufacturing practice knowledge; strong writing; FDA correspondence experience; RAC preferred.
GDUFA, FDA regulations, ICH, cGMP, SOPs, CAPA
2mo
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Senior Project Engineer
Elma, New York, United States
$100k/yr OnsiteFull Time
7+ YOELead cross-functional engineering projects in FDA-regulated beverage manufacturing; 7+ years experience; capital project management; cGMP/HACCP/FDA/OSHA knowledge; BS/MS in engineering; MBA a plus.
CAD, Project Management, PFDs/P&IDs, cgmp, HACCP, FDA, OSHA
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