6d
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Healthcare & FDA Regulatory Law Expert
New York, New York, United States
$100-$200/hr RemoteContract, Part Time
3+ YOEJ.D. and bar admission; 3+ years U.S. healthcare law or FDA regulatory practice; strong knowledge of HIPAA, Anti-Kickback, Stark Law, False Claims Act; excellent writing and analytic skills.
ChatGPT, LLM
2mo
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Clinical Research Coordinator 2
New Haven, Connecticut, United States
$65k-$101k/yr OnsiteFull Time
2+ YOECoordinate clinical trials; manage screening, eligibility, recruitment; ensure compliance with GCP, FDA, HIPAA; independent multi-study management; strong communication.
GCP, FDA Regulations, HIPAA, EMR, Clinical Trial Management Systems
1mo
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Compounder
Norwood, New Jersey, United States
$21-$25/hr OnsiteFull Time
2+ YOEHigh school diploma/GED, 2+ years fragrance or flavor compounding experience, ability to operate mixers/pumps/scales and forklifts, follow cGMP/FDA procedures, wear PPE, and work overtime as needed.
mixers, pumps, scales, forklift, GMP, cGMP, FDA
1mo
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Quality Engineer (Bridgeport, CT, US, 06610-0156)
Bridgeport, Connecticut, United States
OnsiteFull Time
3+ YOEBachelor's in engineering, 3+ years quality experience with metrology/CMM, GD&T, SPC/DOE, ISO and FDA QSR knowledge, blueprint reading, statistical analysis, and ability to lead inspections and corrective actions.
CMM, optical comparators, micrometers, calipers, gage blocks, pin gages, Gage R&R, GD&T, DOE, SPC, ISO, FDA, ECNs, SCRs, Material Review Board (MRB)
1mo
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Operations Supervisor
Melville, New York, United States
$60k-$80k/yr OnsiteFull Time
3+ YOELead FDA sampling operations, supervise samplers, manage scheduling, ensure FDA compliance, and coordinate with laboratory and client teams. Requires 3+ years related experience and supervisory experience preferred.
Microsoft Office
4d
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Regulatory Affairs/Quality Affairs Specialist
Baldwin, New York, United States
$75k-$87k/yr OnsiteFull Time
3+ YOEBachelor's in biomedical/RA/QA or related,3+ years FDA-regulated medical device experience,510(k) and post-market/CAPA experience,RAC preferred,audit and FDA/EU/ISO13485 knowledge,strong communication and PC skills.
2mo
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Research Coordinator
New York, New York, United States
HybridFull Time
2+ YOEBachelor’s degree required; 2+ years in clinical research; certifications preferred; REDCap/EHR experience; HIPAA/FDA knowledge.
REDCap, EPIC, IRB Management Platforms, CTMS SMART
1mo
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Regional Regulatory Affairs Lead, US
New York, New York, United States
$191k-$234k/yr HybridFull Time
8+ YOE8+ years in medical device regulatory affairs with 5+ years on FDA-regulated devices; accountable lead on 510(k)/De Novo/PMA; direct FDA engagement; able to hold US Agent/Initial Importer/Distributor roles; experience building RA processes and teams; degree required; experience using AI for regulatory workflows.
2mo
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Quality Assurance Supervisor- New York City
Long Island City, New York, United States
$70k-$85k/yr OnsiteFull Time
5+ YOE1+ MgmtBachelor's required; 5+ years QA in cosmetics/pharma; prior QA leadership; strong FDA/cGMP and cosmetic/OTC compliance knowledge.
2mo
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FSQA Quality Assurance Technician - 1st shift
Meriden, Connecticut, United States
$18/yr OnsiteFull Time
2+ YOEQA role in manufacturing; high school required; 2-3 years experience preferred; FDA/GMP knowledge preferred; basic Excel skills.
Excel
2w
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Principal Microbiologist
Stamford or Trumbull
$110k-$120k/yr OnsiteFull Time
10+ YOE10+ years industry microbiology experience with preservation, antibacterial product development, regulatory interpretation (FDA), complex study design, manufacturing microbiology, and leadership.
2mo
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Study Manager
New York City, New York, United States
OnsiteFull Time
5+ YOE5–7 years coordinating multi-site clinical studies; IRB submissions; site management; ICH-GCP; HIPAA; FDA knowledge; strong organization.
EDC, IRB platforms, eTMF, protocols, spreadsheets, data management
2w
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Manager, Regulatory Affairs Strategy - Oncology
Tarrytown or Warren
$129k-$210k/yr HybridFull Time
2+ YOEDoctorate (MD/PhD/PharmD) and 2+ years regulatory experience; experience with INDs/CTAs, agency interactions, filings, and knowledge of US FDA and international regulations.
2mo
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Clinical Research Coordinator
Secaucus, New Jersey, United States
$50k-$52k/yr OnsiteFull Time
1+ YOE1+ year clinical research experience preferred, BS/MS in biology/chemistry preferred, knowledge of GCP and FDA regulations, strong communication and organizational skills.
4d
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Senior Professional Regulatory Affairs - Lifecycle Management - Medicines
Bronx, New York, United States
HybridFull Time
5+ YOE5+ years regulatory affairs experience with lifecycle management, FDA interactions, leading complex post-approval changes, and coaching peers; scientific/technical degree preferred.
2mo
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Regional Quality Manager (Fort Lee, NJ, US, 07024)
Fort Lee, New Jersey, United States
OnsiteFull Time
5+ YOEFive+ years in plasma or regulated industry; knowledge of FDA/EMA requirements; cGMP and quality systems; travel up to 90%; remote/multi-site team management.
1w
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QA Sr. Specialist - CAPA
Shirley, New York, United States
$80k-$95k/yr OnsiteFull Time
5+ YOEBachelor's in science/engineering,5+ years QA experience in regulated environment,knowledge of FDA regulations,CAPA writing and risk management,strong analytical and organizational skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
2w
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Account Executive, Earned Media - Health & Wellness
New York, New York, United States
$35k-$75k/yr HybridFull Time
1+ YOE1–2 years PR/media relations experience, bachelor's preferred, strong writing and communication, familiarity with healthcare/pharmaceutical communications and MLR/FDA processes preferred.
Cision, Muck Rack, Meltwater
2mo
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Sr. Manager, Quality Excellence
Hauppauge, New York, United States
$155k-$175k/yr OnsiteFull Time
7+ YOE5+ MgmtExtensive leadership in Quality, QA/QC, and manufacturing operations in FDA/EPA-regulated environments; ISO 9001/13485; Lean and Six Sigma; strong governance and QMS experience.
SAP, Oracle, Veeva, Magic
2mo
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Quality Assurance Manager - Food Safety (Jamaica, NY-New York, US, 11430)
Jamaica, New York, United States
$95k-$112k/yr OnsiteFull Time
5+ YOE2+ MgmtBachelor's in Food Science/related; PCQI and HACCP; 5+ years in food safety; 2+ years in management; knowledge of FDA FSMA, cGMP, USDA; strong leadership and communication.
Microsoft Office, Cloud-based systems, Scanner, Tablet, Printer
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