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.
Director, Regulatory Advertising and Promotion (Whippany, New Jersey, US)
Whippany, New Jersey, United States
$170k-$255k/yrOnsiteFull Time
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.
Quality Systems Manager – Medical Device Manufacturing
Fairfield, New Jersey, United States
OnsiteFull Time
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
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.
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.
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.
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.
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.
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/yrHybridFull Time
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
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.
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
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
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.
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.
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.
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.
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.