- Eliassen Group (Boston, MA)
- ** Software Engineer** **Anywhere** **Type:** Contract-to-Hire **Category:** Development **Industry:** Life Sciences **Workplace Type:** Remote **Reference ID:** JN ... Jobs **Description:** Our client is hiring for an iOS Software Engineer to join their team in San Diego,...PLUS: Bluetooth experience & Any industry experience that has FDA requirements OR enterprise level company experience and documentation.… more
- Capgemini (Burlington, MA)
- …with relevant medical device regulations such as ISO 13485, IEC 62304, and FDA guidelines. . Defect Management: Lead root cause analysis and resolution of defects, ... proper traceability and documentation. . Cross-functional Collaboration: Work closely with software , hardware, and QA teams to synchronize verification efforts with… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients ... ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers… more
- Sumitomo Pharma (Boston, MA)
- …including computer word processing, electronic document management systems, and regulatory publishing software . + Robust understanding of FDA and other health ... + Distributing, and archiving all incoming and outgoing communications with FDA and international counterpart agencies. + Understands evolving Health Authority (HA)… more
- Hologic (Marlborough, MA)
- …gain immense satisfaction by enabling healthier lives everywhere, every day. Our Software Engineering (R&D) department in our Diagnostics division is looking for a ... representative ensuring that our products are meeting industry standards and FDA requirements throughout the product lifecycle, including post-market. This is a… more
- Tecomet (Woburn, MA)
- …improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations. This is accomplished by maintaining Tecomet principles ... Technical Files, and Design Dossiers and Change Notices. + Serve as Official FDA Correspondent. + Serve as person responsible for regulatory compliance (PRRC). +… more
- Philips (Cambridge, MA)
- … FDA regulated Medical Device/HealthTech product environments. Experience with Software as Medical Device (SaMD) and Ultrasound Imaging Devices highly desired. ... product development projects, ensuring our state-of-the-art Ultrasound Products meet FDA , and other governmental agency/notified body Regulatory Compliance standards/requirements.… more
- J&J Family of Companies (Danvers, MA)
- …as the subject matter expert (SME) for process validation, ensuring alignment with FDA 21 CFR Part 820, ISO 13485, and other applicable regulations and standards. ... both manual and automated assembly processes. + Strong working knowledge of FDA , ISO, and GHTF validation requirements, including IQ/OQ/PQ frameworks. + Proven… more
- Integra LifeSciences (Braintree, MA)
- …art facility in Braintree, MA in 2025. + Adequate knowledge of learning management software . + Experience in GMP and quality systems regulations ( FDA QSRs, ISO ... training events in a manufacturing setting. + Knowledge of Microsoft Office software applications including Microsoft Excel. Ability to develop charts and trend… more
- Catalent Pharma Solutions (Chelsea, MA)
- …portion of expansion and upgrade projects + Performs and documents hardware/ software modifications to existing systems. Ensures that all automation designs and ... assessments and GMP evaluations of control systems to ensure they meet FDA requirements. Prepares standard operating procedures for new and existing control… more