- Fujifilm (Boston, MA)
- …technical aspects of Synapse product HL7 integration, from install, configure and validation phases through product go-live, for all Synapse MI products. HL7 IE's ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Takeda Pharmaceuticals (Boston, MA)
- …case processing, MedDRA coding) is highly desirable + Knowledge of data integrity, system validation , and computer system compliance (21 CFR Part 11, EU GVP) + ... including but not limited to requirement specifications, functional specifications and validation documents + Lead E2B program expansion based on business needs… more
- Bristol Myers Squibb (Devens, MA)
- …their work. + Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Solves ... Authority requirements. **Knowledge and Skills:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. + Must… more
- Cardinal Health (Boston, MA)
- …(California Consumer Privacy Act), FDA (Food and Drug Administration)/GxP/CSV ( Computer System Validation ), DSCSA(Drug Supply Chain Security Act), as well ... as relevant governance frameworks to drive compliance to those regulatory requirements such as NIST, HITRUST, SOC 2, ISO, COBIT, ITIL, etc., while working with members of the Information Security and Risk Management team as well as stakeholders from Finance,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Affairs' efforts in creating submission materials for various regulatory domains including FDA , PMDA, and EU-MDR. **Job Duties** + Advise SW development teams on ... and activities for the inclusion of ML/AI development, cloud infrastructure, and validation best practices. + Collaborate on the update of SDLC and operations… more
- Medtronic (Newton, MA)
- …efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO 13485. + Serve as member of ... requirements, design, development, integration, test protocols, test reports, verification, validation , and tooling. Ensure all documentation meets reliability standards… more
- Medtronic (Boston, MA)
- …assessment through to procedure production release including equipment installation and validation activities + Lead development of a system-based approach for ... the project lifecycle + Medical device / regulated / FDA environment + Developed and implemented culture change +...The employee is also required to interact with a computer , and communicate with peers and co-workers. Contact your… more
- Medtronic (Boston, MA)
- …design, code implementation, unit test, and software and system verification and validation . + You will also participate in SAFe/Agile activities including but not ... and regulation - ISO 13485 and 14971, GMP guidelines, FDA regulations, Software as medical devices, and IEC 62304....The employee is also required to interact with a computer , and communicate with peers and co-workers. Contact your… more
- Medtronic (Boston, MA)
- …trade-off decisions for resource prioritization. * Collaborate with Verification & Validation , Systems Engineering, and Regulatory Affairs to ensure appropriate test ... Resource First + Experience working under regulations of the FDA , notified bodies, and other regulatory agencies for successful...The employee is also required to interact with a computer , and communicate with peers and co-workers. Contact your… more
- Bristol Myers Squibb (Devens, MA)
- …installations, configurations, administrative and support functions including system validation lifecycles and training. + Provide local administrative support ... **Qualifications** + BS degree in life sciences, engineering or computer field or equivalent experience. + Minimum of 2+...SOPs, cGMPs and other compliance requirements and regulatory guidelines ( FDA , EU) and the know how to work and… more