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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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Director, Manufacturing Quality, GIS (Japan Based) (Center Valley, PA, US, 18034-0610)
Center Valley or Aizu
$135k-$189k/yr OnsiteFull Time
10+ YOE10+ years quality experience in regulated environment; FDA QSR/ISO 13485 knowledge; ASQ preferred; must relocate for Japan assignment.
FDA QSR, ISO 13485, MDR, CAPA, DHF, DMR, DHR
2mo
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Director, Regulatory Advertising and Promotion (Whippany, New Jersey, US)
Whippany, New Jersey, United States
$170k-$255k/yr OnsiteFull Time
8+ YOEExtensive knowledge of US FDA regulations for prescription drug advertising; experience leading OPDP submissions; strong analytical, regulatory, and cross-functional collaboration.
FDA, OPDP, Regulatory Affairs, Promotional Review
2mo
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Quality Systems Manager – Medical Device Manufacturing
Fairfield, New Jersey, United States
OnsiteFull Time
10+ YOE10+ years in medical device quality systems; ISO 13485 and FDA QSR experience; manage QMS, audits, and regulatory readiness; Bachelor’s in Engineering or Quality.
Electronic QMS platforms, ISO 13485, FDA QSR, 21 CFR Part 820
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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Senior Manager, Regulatory Affairs - OTC
Warren, New Jersey, United States
$153k-$210k/yr HybridFull Time
7+ YOEBachelor's in pharmaceutical/life sciences required, 7+ years regulatory affairs experience (FDA/OTC/CMC), proven leadership, FDA interaction experience, strong communication and project management skills.
1mo
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Associate Director, REMS Operations (68770)
Parsippany or West Chester or United States
$159k-$194k/yr HybridFull Time
7+ YOEBachelor's degree, 7+ years program/project management in regulated industry (preferably pharma), 2+ years working with FDA, vendor management, FDA/REMS regulatory expertise, MS365 skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, MS Project, MS365, database
1mo
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Director REMS Operations
Parsippany, New Jersey, United States
$170k-$213k/yr HybridFull Time
10+ YOEBachelor's degree, 10+ years managing large regulated programs, 5+ years working with FDA preferred, experience with REMS and vendor management, strong project management, communication, and FDA regulatory knowledge.
1mo
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Associate Director, Regulatory Affairs Advertising & Promotions
Monmouth Junction, New Jersey, United States
$180k-$225k/yr HybridFull Time
7+ YOEBachelor's in life sciences/pharmacy/medicine, minimum 7 years regulatory review experience for advertising/promotional materials in pharma/biotech, in‑depth FDA/OPDP knowledge, ability to influence, and experience preparing FDA submissions.
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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.
1mo
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Manager, Regulatory Affairs
Edison or United States or Canada or Australia
$99k-$125k/yr RemoteFull Time
7+ YOE5+ MgmtBachelor's in science or equivalent, 7+ years experience, 5+ years managerial experience, 5+ years in human tissue or medical device manufacturing, strong knowledge of FDA/QSR/cGMP/ISO, experience with FDA inspections and regulatory submissions; up to 20% travel.
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
2mo
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Associate Director, Regulatory Affairs - Biosimilars (US)
Princeton, New Jersey, United States
$146k-$279k/yr HybridFull Time
7+ YOE7+ years regulatory affairs in biopharma with US biosimilar experience; FDA submissions; strong cross-functional leadership and communication.
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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Director, Regulatory Affairs
Jersey City, New Jersey, United States
$213k-$233k/yr HybridFull Time
10+ YOE10+ years regulatory affairs experience; FDA and international regulatory knowledge; clinical regulatory content and submissions; strong communication; individual contributor.
eCTD, Regulatory submissions
2mo
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Medical Oncologist / Principal Investigator
East Brunswick, New Jersey, United States
OnsiteFull Time
MD with board certification in hematology and/or medical oncology; clinical trials experience; knowledge of GCP, FDA regulations; strong collaboration and communication skills.
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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Foreign Medical Graduate (FMG)
Jersey City, New Jersey, United States
OnsiteFull Time
5+ YOEFMG with at least 5 years of clinical research experience; supervisory experience preferred; proficient in ICH-GCP, FDA regulations, and study conduct.
EDC, IVRS
2mo
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Senior Manager, Regulatory Affairs - OTC
Warren, New Jersey, United States
$153k-$210k/yr HybridFull Time
7+ YOEBachelor’s in Pharmaceutical or Life Sciences; 7–10 years regulatory affairs; US FDA; OTC monograph; strong communication and project leadership.
1mo
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Senior Copywriter
Cedar Knolls, New Jersey, United States
OnsiteFull Time
4+ YOE4+ years agency copywriting experience in pharmaceutical/healthcare; strong portfolio, FDA/MLR familiarity, presentation skills, collaboration, and proficiency with Word and PowerPoint.
Microsoft Word, Microsoft PowerPoint, Teams, Slack, Veeva PromoMats
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