Role Title: Associate Director, Radiology IND/IDE Support Office
Philadelphia, Pennsylvania, United States
$81k/yrHybridFull Time
University of Pennsylvania: Research university offering higher education and healthcare services.
7+ YOEBachelor's degree in a scientific or related discipline and 7–10 years as a monitor or equivalent experience. Requires FDA-regulated clinical research experience with IND/IDE studies and knowledge of FDA compliance requirements.
FDA, Good Clinical Practice (GCP), Trial Master File, case report forms
Role Title: Associate Director, Radiology IND/IDE Support Office
Philadelphia, Pennsylvania, United States
$81k/yrHybridFull Time
University of Pennsylvania: Provides Ivy League higher education and conducts advanced scientific research.
7+ YOEBachelor's degree in a scientific or related discipline and 7–10 years as a monitor or equivalent experience. Requires FDA-regulated IND/IDE research, FDA regulations, GCP, regulatory compliance, and clinical research operations expertise.
FDA, Good Clinical Practice (GCP), Trial Master File, case report forms, risk-based monitoring
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.
Sharp: Provides contract packaging and clinical services for life sciences.
5+ YOERequires a bachelor's degree in a technical discipline or 5 years of related experience in an FDA-regulated medical or pharmaceutical industry, plus supervisory and production management expertise.
Dutch Ophthalmic Research CenterFrankfurt Stock Exchange: AFX: Manufactures surgical equipment and instruments for eye surgery.
5+ YOERequires 5+ years in senior medical device or pharmaceutical quality assurance, FDA or Notified Body inspection experience, people management, advanced Microsoft Office, and fluent English.
Eugia: Developer and manufacturer of generic sterile injectable pharmaceuticals.
10+ YOEBachelor’s degree in a scientific discipline and 10+ years of relevant quality compliance experience with leadership responsibility, FDA inspections, GxP systems, audits, vendor oversight, and pharmacovigilance compliance.
Eurofins ScientificEuronext Paris: ERF: Global provider of analytical testing and laboratory services.
5+ YOEBachelor's degree in a related field, 5+ years overseeing biocompatibility studies, knowledge of EPA, FDA, DOT, OECD, GLP, and ISO regulations, leadership, administration, communication, and writing skills.
CooperSurgicalNasdaq: COO: Manufactures medical devices for fertility and women's health.
3+ YOERequires 3+ years in regulated quality and supplier management processes, a relevant bachelor's degree or equivalent experience, and knowledge of FDA QSR, ISO 13485, supplier audits, validation, and quality systems.
FDA QSR, ISO 13485, EUMDR, ISO 14971, Change Control Systems, GD&T, Design Control, Microsoft Office, Minitab, ERP, QMS, SCAR, CAPA, NCR, NCMR, IQ, OQ, PQ, PPAP
Mars: Global manufacturer of confectionery, snacks, and pet care products.
6+ YOE5+ MgmtBachelor's degree or equivalent experience, 6+ years in a related role, 5+ years leading teams, manufacturing expertise, lean methods, HACCP, FDA and OSHA requirements, and strong communication skills.
UST: Global provider of digital transformation and IT services.
5+ YOERequires 5–7 years of professional experience; bachelor's degree in packaging engineering preferred. Experience with packaging validation, specifications, component development, skin care or cosmetics, FDA, or GMP preferred.
Amneal PharmaceuticalsNASDAQ: AMRX: Develops and manufactures generic and specialty pharmaceutical products.
1+ YOEBachelor's degree in engineering, pharmaceutics, industrial pharmacy, or related field; 1+ year of relevant experience; process validation, manufacturing, statistical analysis, SOP, RCA, CAPA, FDA, and cGMP knowledge.
LSG Sky Chefs: Global provider of airline catering and in-flight hospitality services.
High school diploma or equivalent; ability to work in cold, standing for long periods; follow food safety (USDA/FDA/HACCP), use kitchen equipment, basic math and English communication.
Sonder Research X: Developing advanced diagnostic technologies for early cancer detection.
5+ YOEBachelor's degree in a scientific discipline and 5–8+ years in regulatory affairs or quality systems within biotechnology, diagnostics, medical devices, or regulated life sciences; FDA and QMS experience required.
Quality Management System (QMS), Standard Operating Procedures (SOP), Corrective and Preventive Actions (CAPA), FDA, CLIA, CAP, ISO 13485, Laboratory-Developed Tests (LDTs), In Vitro Diagnostics (IVDs), Coursera
Canfield Scientific: Develops specialized photographic systems for medical and pharmaceutical research.
3+ YOEAssociate degree or 3 years of experience; knowledge of FDA, ISO 13485, and ISO 9001 regulatory processes; Microsoft Office proficiency; strong organization, multitasking, communication, and time management skills.
Fingerpaint Group: Marketing and commercialization services for the healthcare industry.
4+ YOEBachelor's degree and 4–7 years of pharmaceutical advertising agency experience, including client management, project execution, MLR review, FDA regulations, brand operations, digital advertising, and multichannel strategy.
Associate Technical Writer (Deviation Assessment), CAR-T Manufacturing Technical Support
Summit, New Jersey, United States
OnsiteFull Time
Bristol Myers SquibbNew York Stock Exchange: BMY: Develops and distributes innovative medicines for serious diseases.
2+ YOEKnowledge of cGMP manufacturing or quality and FDA-regulated industry practices; strong technical and compliance writing, communication, critical thinking, multitasking, and MS Office skills. Degree or equivalent manufacturing experience required.
TeleflexNYSE: TFX: Manufactures medical devices for critical care and surgical procedures.
15+ YOEBachelor’s degree and 15 years in medical devices with increasing responsibility and commercial experience. Requires interventional market expertise, Class 3 PMA experience, clinical trials, FDA panels, and CMS reimbursement knowledge.
R&D, P&L, FDA, CMS, Global Supply Chain (GSC), Quality Assurance and Regulatory Affairs (QARA)
Blommer Chocolate Company: Produces and supplies chocolate and cocoa ingredients for manufacturers.
High school diploma or equivalent preferred; ability to operate and adjust machinery, perform quality checks, handle materials up to 50 pounds, and follow OSHA, GMP, FDA HACCP, and allergen management requirements.