- Fujifilm (Boston, MA)
- …Speech Recognition tools, as well as actual dictation functionality when Fuji Dictation software is utilized. + Maintains a clear understanding of FDA ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Charles River Laboratories (Boston, MA)
- …guidelines and standards that relate to animal care and use (Eg, USDA, FDA , AAALAC). + Make recommendations and assist in establishing and enhancing veterinary and ... + Other: Computer literacy in word processing, spreadsheet and database software . Ability to organize, prioritize work and meet deadlines. Good communication… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …understanding of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory ... etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable. **Competencies** **Accountability for… more
- Integra LifeSciences (Braintree, MA)
- …Process Validation, or other studies as deemed necessary. + Participate in FDA inspections, ISO Certification and surveillance audits, customer audits and internal ... + Proficient with the MS Office Suite, and statistical software . + Must be able to work independently with...with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + Knowledge of TrackWise preferred. + Knowledge of… 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
- Fujifilm (Boston, MA)
- …trends, best practices, regulations, and a wide range of hardware and software products. This position requires interaction with sales, technical support, field ... point of contact between Engineering and Integration for new products, software changes including testing, and new information dissemination. Responsible in… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... in Healthcare / Radiology Informatics product marketing. + Extensive experience in software promotion. + Extensive experience managing software product roadmaps… more
- Fujifilm (Boston, MA)
- …Technical Assistance Center (TAC). + Participate in Clinical Validations Testing for each software release of the product to further enhance the overall accuracy of ... with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard...+ Proven experience in related field. + Healthcare or software application or IT industry background a plus. +… more
- Charles River Laboratories (Shrewsbury, MA)
- …meet deadlines under minimal direction. Proficiency in the use of standard software including Microsoft(R) Excel, Word, Powerpoint, etc. and with standard laboratory ... calculations. Proficiency in the use of analytical instrumentation software . The pay for this position is $29.00 USD....development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories… more
- Fujifilm (Boston, MA)
- …Technical Assistance Center (TAC). + Participate in Clinical Validations Testing for each software release of the product to further enhance the overall accuracy of ... I. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more