- Fujifilm (Macedonia, OH)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally...as required, absent being granted an accommodation due to medical or sincerely held religious belief or other legally… more
- West Pharmaceutical Services (Scottsdale, AZ)
- …Why's, 6M's, 8D's, and DMAIC. + Regulatory Knowledge: In-depth understanding of Medical Device Regulatory Requirements and Standards, including 21 CFR ... or Quality Assurance or Quality Engineering role(s) specifically within medical devices is essential ( medical device manufacturing preferred). + Proven… more
- Gilead Sciences, Inc. (La Verne, CA)
- …This position will support **Parenteral Packaging** (eg, vials, syringes, stoppers) and ** Device categories** . The role is designed to provide hands-on operational ... processes) + Stoppers (knowledge of coring, particulate investigations) + Devices (manual needle guard issue resolution, auto-injector issues, component… more
- Integra LifeSciences (Princeton, NJ)
- …and execute plans. + Deep knowledge of global sourcing, contract manufacturing, and regulatory compliance in medical devices . + Strong leadership, ... and Operations to ensure alignment across product lifecycle phases and compliance with medical device regulations (eg, FDA, ISO 13485, MDR). Ensure supplier… more
- Amgen (Juncos, PR)
- …the lives of patients while transforming your career. **PROCESS DEVELOPMENT SCIENTIST ( DEVICES & PACKAGING)** **What you will do** Let's do this. Let's change ... qualify new and existing products in the packaging environment, implement new devices and configurations. You'll collaborate across teams to optimize systems, drive… more
- Insight Global (Bedford, MA)
- …components. Performing Supplier Audits: Conduct FDA audits and ensure suppliers meet regulatory standards specific to medical devices . Manufacturing ... experienced Quality Engineer to join our team in the medical device industry. The ideal candidate will...quality engineering, particularly in the assembly of complex, low-volume medical devices . This role involves close collaboration… more
- Lilly (Indianapolis, IN)
- …develop a global regulatory strategy which supports product (including delivery device and relevant medical devices ) development, registration, and ... all in-scope countries for assigned products/programs, bringing in regional, CMC and Device regulatory scientists as needed. + Consistently communicate well… more
- Lilly (Indianapolis, IN)
- …develop a global regulatory strategy which supports product (including delivery device and relevant medical devices ) development, registration, and ... all in-scope countries for assigned products/programs, bringing in regional, CMC and Device regulatory scientists as needed. + Consistently communicate well… more
- J&J Family of Companies (Irvine, CA)
- …years of experience in a regulated environment including five years of direct experience with medical devices in the fields of technical or medical writing, ... and governance to related functions ensuring the delivery of key regulatory and medical documents. Specifically, the Associate Director will lead the strategy… more
- Albany Medical Center (Albany, NY)
- …healthcare reimbursement systems and regulatory requirements + Familiarity with medical devices , pharmaceuticals, or healthcare technologies + Project and ... and Value Analysis, this position is responsible for evaluating medical products, services, and technologies to optimize cost-effectiveness while maintaining… more