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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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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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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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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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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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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
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.
5d
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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
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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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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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.
1mo
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Manager, Operations
Edison, New Jersey, United States
$150k-$170k/yr OnsiteFull Time
10+ YOE10+ MgmtBachelor's degree, 10+ years manufacturing management experience, knowledge of packaging operations and FDA guidelines, strong leadership, financial and quality management skills.
2w
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Quality System Specialist II - Document Control
Franklin Lakes, New Jersey, United States
$110k-$176k/yr OnsiteFull Time
2+ YOESupports quality systems and documentation management for engineering and product development; knowledge of FDA/ISO regulations, good documentation practices, and use of quality tools.
SAP, Docusign, PEGA, Trackwise
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
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.
3w
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Customs Specialist
Jersey City, New Jersey, United States
$26-$29/hr OnsiteFull Time
2+ YOE2+ years customs brokerage import experience, proficiency with Cargowise and Microsoft Office, knowledge of CBP regulations, Incoterms, FDA Prior Notice and HTSUS classification.
Cargowise, Microsoft Office Suite, Microsoft Office, CBP, FDA Prior Notice, HTSUS, Incoterms, AI, Artificial Intelligence
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