440 fda jobs at 206 companies in Passaic, NJ

12h
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Healthcare & FDA Regulatory Law Expert
New York, New York, United States
$100-$200/hr RemoteMultiple Commitments Available
Turing
Turing: AI-powered platform connecting companies with global remote software developers.
3+ YOEJ.D. and U.S. bar admission required, plus 3+ years of U.S. healthcare law, FDA regulatory, or healthcare compliance practice. Expertise in HIPAA, Anti-Kickback, Stark, False Claims Act, and FDA regulations.
ChatGPT, CMS, FDA, 510(k), PMA, NDA, LLM
2mo
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Director, Regulatory Advertising and Promotion (Whippany, New Jersey, US)
Whippany, New Jersey, United States
$170k-$255k/yr OnsiteFull Time
Bayer
BayerFrankfurt Stock Exchange: BAYN: Global provider of healthcare medicines and agricultural products.
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
Weiss-Aug Group
Weiss-Aug Group: Provides precision metal stamping and injection molding manufacturing solutions.
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
10h
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Study Director
South Brunswick Township or Dayton
$60k-$67k/yr OnsiteFull Time
Eurofins Scientific
Eurofins ScientificEuronext Paris: ERF: Global provider of analytical testing and laboratory services.
Requires a PhD in science or equivalent experience, testing knowledge, regulatory familiarity with EPA, FDA, DOT, OECD, GLP, and ISO standards, leadership, administration, communication, and report-writing skills.
EPA, FDA, DOT, OECD, GLP, ISO
1d
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Field Services Engineer II
Queens, New York, United States
$38-$50/hr HybridFull Time
Omnicell
OmnicellNASDAQ: OMCL: Provider of automated medication management and pharmacy solutions.
1+ YOERequires engineering, technology, robotics, electronics, or equivalent training; hospital experience; relevant troubleshooting experience; driver's license, vehicle, and acceptable driving record. FDA and quality systems knowledge preferred.
Network Engineering, Robotics, FDA regulations, Quality Management Systems
1d
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Environmental Monitoring Sampler
Summit, New Jersey, United States
$28-$34/hr OnsiteFull Time
Bristol Myers Squibb
Bristol Myers SquibbNew York Stock Exchange: BMY: Develops and distributes innovative medicines for serious diseases.
1+ YOEHigh school diploma or equivalent and 1–2 years of experience in a regulated industry. Requires cGMP/FDA knowledge, MS Office proficiency, technical writing, basic math, and aseptic gowning ability.
Microsoft Office, FDA, USP, PPE, SOPs, cGMP
1mo
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Compounder
Norwood, New Jersey, United States
$21-$25/hr OnsiteFull Time
Phoenix Flavors & Fragrances
Phoenix Flavors & Fragrances: Creates and manufactures custom flavor and fragrance ingredients.
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
1d
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Environmental Monitoring Sampler
Denville, New Jersey, United States
$28-$34/hr OnsiteFull Time
Bristol Myers Squibb
Bristol Myers SquibbNYSE: BMY: Develops and manufactures innovative prescription biopharmaceutical medicines.
1+ YOEHigh school diploma or equivalent and 1–2 years of regulated-industry experience. Requires GMP/FDA knowledge, MS Office proficiency, aseptic gowning, documentation, sample handling, and ability to lift 25 pounds.
Microsoft Office, SOPs, PPE, USP, FDA, cGMP
1d
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Senior Director NA Brand R&D Lead
Morristown, New Jersey, United States
$184k-$265k/yr HybridFull Time
Opella
Opella: Develops and manufactures consumer healthcare and self-care products.
10+ YOEBachelor's degree in a scientific discipline and 10+ years of R&D experience required. Requires OTC and NDA product development, FDA submissions, innovation pipeline leadership, cross-functional team leadership, and consumer health expertise.
R&D, OTC, NDA, FDA
11h
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Clinical Project Manager II – Inflammation Sponsor-Dedicated | Remote (U.S.) Preference for Hybrid Foster City, CA-Based Candidates
United States or Foster City or New York City
$95k-$176k/yr HybridFull Time
Syneos Health
Syneos Health: Global biopharmaceutical services for clinical development and commercialization.
3+ YOERequires 3+ years of clinical project management, regional global-trial leadership, full lifecycle trial experience, Phase 2b inflammation experience, CRO/vendor oversight, and knowledge of FDA, EMA, ICH, and GCP requirements.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, FDA, EMA, ICH Guidelines, GCP, SOP
1mo
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Senior Manager, Regulatory Affairs - OTC
Warren, New Jersey, United States
$153k-$210k/yr HybridFull Time
Haleon
HaleonLondon Stock Exchange, New York Stock Exchange: HLN: Global leader in consumer healthcare and over-the-counter medicines.
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.
1d
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Manager - Quality
Orangeburg, New York, United States
OnsiteFull Time
Mativ
MativNYSE: MATV: Produces specialty materials for filtration, adhesives, and industrial applications.
5+ YOEBachelor’s degree in science or engineering, 5+ years in quality management, ISO 13485 and FDA 21 CFR 820 knowledge, lead audit qualification, and FDA inspection and certification audit experience.
Quality Management System (QMS), ISO 13485, FDA 21 CFR 820, FDA 21 CFR 210, FDA 21 CFR 211, MoCRA, ISO 14971, pFMEAs, Lean Six Sigma
1mo
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Associate Director, REMS Operations (68770)
Parsippany or West Chester or United States
$159k-$194k/yr HybridFull Time
Teva Pharmaceuticals
Teva PharmaceuticalsNYSE: TEVA: Developing and manufacturing generic and specialty pharmaceutical medicines.
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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Operations Supervisor
Melville, New York, United States
$60k-$80k/yr OnsiteFull Time
Certified Group
Certified Group: Provides laboratory testing, regulatory consulting, and certification services.
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
Teva
TevaNYSE: TEVA: Global manufacturer of generic and specialty pharmaceutical products.
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
Tris Pharma
Tris Pharma: Develops and sells medicines for ADHD and neurological disorders.
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.
1w
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Regulatory Affairs/Quality Affairs Specialist
Baldwin, New York, United States
$75k-$87k/yr OnsiteFull Time
Elliquence
Elliquence: Manufactures medical devices for minimally invasive spine and neurosurgery.
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
MTF Biologics
MTF Biologics: Processes human tissue for use in medical transplants.
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
Hospital for Special Surgery
Hospital for Special Surgery: Provides specialized orthopedic, rheumatologic healthcare and medical research.
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
Sandoz
SandozSIX Swiss Exchange: SDZ: Develops and manufactures generic medicines and biosimilar treatments.
7+ YOE7+ years regulatory affairs in biopharma with US biosimilar experience; FDA submissions; strong cross-functional leadership and communication.