- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... effective leadership and partnership with all members of the HCUS Medical Informatics organization and work effectively with other cross-functional departments 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 ... + $49,500 variable comp opportunity + Company Car + Medical , Dental, Vision + Life Insurance + 401k +...against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... (Hospital Information System), RIS (Radiology Information System), and EMR(Electronic Medical Record). + Excellent verbal and written communication and presentation… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... to support the needs associated with training others on the operation of medical imaging equipment and conveying to the Fujifilm organization the status of the… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally...as required, absent being granted an accommodation due to medical or sincerely held religious belief or other legally… more
- J&J Family of Companies (Raynham, MA)
- …of professional regulatory experience** in a highly regulated industry, preferably in medical device or pharmaceutical ( _1+ years with Advanced Degree_ ). + ... Demonstrated intellectual capacity to identify, read, understand, and address global medical device regulations are **required** . + Experience in the… more
- Cardinal Health (Boston, MA)
- …regulation) preferred * Experience in private practice strongly preferred * Familiarly with medical device and pharmaceutical regulation * Active license in good ... **_What Regulatory contributes to Cardinal Health_** Legal provides the...regulations; and other product-specific environmental / sustainability drug and device lifecycle obligations and stewardship programs. This role will… more
- Takeda Pharmaceuticals (Boston, MA)
- …years of overall biopharmaceutical/ device industry experience with 8+ years of direct Regulatory CMC or Regulatory Device experience required. This can ... in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory … more
- Danaher Corporation (Boston, MA)
- …diagnostic regulations on the development and registration activities for the respective medical products + Develop and manage regulatory submissions (eg, ... provide inputs and updates to, business and clinical goals. + Provide device -specific regulatory insight/guidance during CDx / Pharma partner cross-functional… more
- Grifols Shared Services North America, Inc (Worcester, MA)
- …submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of ... more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has… more