- Bristol Myers Squibb (Devens, MA)
- …data flow and strong information security. + Ensure strict adherence to GxP, FDA , and other applicable regulatory standards in system implementation, validation, ... understanding of CSV (computer system validation), data integrity, and regulatory requirements in laboratory environments. + Proven leadership, people management,… more
- Cytel (Boston, MA)
- …comfortable interfacing with **senior executives** . + Experience interacting with ** regulatory agencies ( FDA /EMA)** and **key opinion leaders (KOLs)** . ... collaborating with a team of consultants and analysts to define optimal ** regulatory , clinical, and/or market access pathways** . + Develop **innovative solutions**… more
- AbbVie (Worcester, MA)
- …SCADA, and Data Historian systems. + Ensure all automation systems comply with regulatory requirements ( FDA , cGMP, etc.). + Mitigates risk within functions ... responsible to provide the necessary support during the internal and external regulatory audits. Qualifications + Bachelor's degree in computer science or related… more
- J&J Family of Companies (Danvers, MA)
- …sustainability. + **Safety, Quality & Regulatory Compliance** + Maintain alignment with regulatory expectations (eg, FDA QSR/21 CFR Part 820, ISO 13485) and ... This role owns scale-up, process validation, root-cause investigations, safety, regulatory compliance, and continuous improvement initiatives. You will mentor… more
- Cognizant (Boston, MA)
- …systems. + Manage Computer System Validation (CSV) activities in alignment with global regulatory standards ( FDA , EMA, MHRA). + Utilize ALM tools to streamline ... testing workflows and ensure traceability across the validation lifecycle. + Collaborate with R&D and business teams to align testing efforts with project goals and timelines. **Work model:** We believe hybrid work is the way forward as we strive to provide… more
- ThermoFisher Scientific (Plainville, MA)
- …facts; draw valid conclusions; and make decisions. + Thorough understanding of regulatory guidelines ( FDA , EMA, and other relevant authorities). + Excellent ... troubleshooting skills with the ability to resolve complex technical issues. + Strong interpersonal and communication skills, both verbal and written. **Work Environment/Physical Requirements** + This position requires working regular business hours and, when… more
- Philips (Cambridge, MA)
- …with medical device products or medical device integration and working with the FDA and other global regulatory bodies. + Familiarity with healthcare technology ... solutions like EPIC, Cerner, etc., preferred. + Experience working directly with hospital/health systems customers in technical, clinical, and leadership roles and the creation of compelling value propositions for these roles. + Experience with integration… more
- Deloitte (Boston, MA)
- …support. + Regulatory Compliance: Ensure all solutions and processes meet global regulatory requirements (eg, FDA , EMA, PMDA) and industry best practices. + ... You will lead and deliver complex projects that drive innovation, regulatory compliance, and operational excellence for pharmaceutical, biotech, and medical device… more
- Takeda Pharmaceuticals (Lexington, MA)
- …sure that the HFE work is done in compliance with IEC 62366 & regulatory body (example, FDA ) expectations. Drive HF/UX initiatives in early stage, development, ... Summary report etc.) in compliance with IEC 62366 & regulatory agency expectations + Provide input to Use-Related Risk...formative and summative studies. + Familiarity with IEC 62366-1/2, FDA HF Guidance, EU MDR usability expectations + Working… more
- Dana-Farber Cancer Institute (Boston, MA)
- …the appropriate regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA) + Support the maintenance of the ... deviation, violation, exception, or other event reporting. Ensure various regulatory reporting required are met, Study Sponsor, FDA... regulatory reporting required are met, Study Sponsor, FDA , IRB etc. + Serve as facilitator for study… more