- Oracle (Richmond, VA)
- …regulatory, and product leadership teams to align development activities with ISO 14971, IEC 62366, and EU/US Clinical Evaluation standards. Key Responsibilities ... . Conduct and contribute to clinical risk analyses (per ISO 14971). . Collaborate on Failure Mode and Effects...within healthcare technology or medical devices. . Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance… more
- Oracle (Richmond, VA)
- …documentation, Traceability Matrices, and Verification Plans. + Update and maintain ** ISO 14971-compliant risk management files** , hazard analyses, and FMEAs. + ... Experience with one or more of: + MDR (Medical Device Regulation) + ISO 14971 (risk management) + ISO 13485 + IEC 62304 + SaMD (Software as a Medical Device)… more
- Oracle (Richmond, VA)
- …its development and regulatory processes to meet heightened FDA, MDR, and ISO 14155 standards and address ongoing patient safety, compliance, and product ... regulated healthcare software sectors. . Extensive experience in FDA, MDR, and ISO 14155 compliance, clinical risk management, and clinical evaluation for software… more
- Imagine One Technology & Management (Arlington, VA)
- …programs; profit sharing; advancement opportunities; and much more! **_ISO 9001:2015, ISO 20000-1:2018, ISO 27001:2013_** **_CMMI Development and Services - ... Maturity Level 3_** **_An Employee-Owned Business_** **_EEO/Veterans/Disabled_** more
- Imagine One Technology & Management (Arlington, VA)
- …programs; profit sharing; advancement opportunities; and much more!** **_ISO 9001:2015, ISO 20000-1:2018, ISO 27001:2013_** **_CMMI Development and Services - ... Maturity Level 3_** **_An Employee-Owned Business_** **_EEO/Veterans/Disabled_** more
- ENTRUST Solutions Group (Richmond, VA)
- …billing concerns. + **Compliance and Process Improvement:** Ensure adherence to ISO standards, HR, safety, and company policies. Continuously enhance employee, ... client, and operational experiences. Enforce ISO compliance through accountability and training. + **Cross-Functional Collaboration:** Partner with centrally managed… more
- ThermoFisher Scientific (Middletown, VA)
- …quality assurance processes to ensure compliance with FDA 21 CFR Part 820, ISO 13485, IVDR, and GMP requirements. + Partner with Operations, Technical Operations, ... roles. + Experience with quality system regulations and standards (FDA QSR, ISO 13485, ISO 14971, GMP). + Hands-on experience with CAPA, root cause analysis,… more
- Imagine One Technology & Management (Norfolk, VA)
- …programs; profit sharing; advancement opportunities; and much more! **_ISO 9001:2015, ISO 20000-1:2018, ISO 27001:2013_** **_CMMI Development and Services - ... Maturity Level 3_** **_An Employee-Owned Business_** **EEO/vets/disabled** more
- ThermoFisher Scientific (Middletown, VA)
- …**What will you do?** + Facilitate risk management activities in compliance with ISO 14971:2019. Maintain risk management files up to date. + Review and approve ... medical device industry or pharmaceutical industry + Direct experience working with ISO 13485:2016 and 21 CFR 820 required **Knowledge, Skills, Abilities** + Strong… more
- Imagine One Technology & Management (Arlington, VA)
- …programs; profit sharing; advancement opportunities; and much more!** **_ISO 9001:2015, ISO 20000-1:2018, ISO 27001:2013_** **_CMMI Development and Services - ... Maturity Level 3_** **_An Employee-Owned Business_** **_EEO/Veterans/Disabled_** more