- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Technical Files, etc.) + Develop and implement global regulatory strategy for MMS Dispensing Medical Device and non- Medical device products and software ... to comply with new and existing regulations (eg, FDA Medical Device Regulations, EU-MDR) + Support the...Ability to represent Regulatory Affairs in multiple environments (eg Marketing , R&D, and compliance) and work with all levels… more
- J&J Family of Companies (Irvine, CA)
- …in the development of scientific communications and evidence dissemination plans in a medical device or related industry, is versed in supervising personnel ... writing and editing manuscripts, is knowledgeable of the cardiac arrhythmia medical device industry, and is familiar with pertinent regulations and guidelines… more
- Fujifilm (Sacramento, CA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... participating in clinical studies and broader collaboration with the marketing organization. The incumbent is responsible for supporting the...with a Master's degree. + Minimum 8 years of medical device industry experience in a clinical… more
- Abbott (San Francisco, CA)
- …relevant technical field, engineering or equivalent/related experience + 5+ years clinical medical device experience or equivalent, ideally with Leadless CRM ... and present effectively written and verbal communications. + Thorough familiarity with medical device industry policies, operations and procedures. + Expert… more
- Abbott (Pleasanton, CA)
- …Engineering organization. Accountable for delivering scalable, reliable, high-performance, innovative medical device software and non-regulated digital health ... engineering. Master's Degree preferred. + Software development experience required in medical device , digital health, and/or other highly regulated industry.… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …new and existing US and international regulations and directives (eg, FDA Medical Device Regulations, EU Low Voltage Directive, EU Electromagnetic Compatibility ... of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to...five (5) years of Regulatory Affairs experience in the medical device industry required + Strong prioritizing,… more
- Abbott (Milpitas, CA)
- …engineering field. + 10-15 years of management and technical management experience in the medical device industry with minimum 5 years at a senior management ... error analysis, usability and validation testing. + Extensive knowledge of entire medical device development process from needs definition through regulatory… more
- Edwards Lifesciences (Irvine, CA)
- …or related field with 15+ years of relevant Engineering experience with 10+ years in medical device -OR- + Master's degree in engineering or related field with ... 14+ years of relevant Engineering experience with 10+ years in medical device + 5+ years of experience by showing a demonstrated track record in leadership… more
- Fujifilm (Sacramento, CA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... 5+ years of progressive experience in the product sales, product marketing at a Healthcare / Medical Imaging / IT organization. + Broad functional experience in… more
- Fujifilm (Sacramento, CA)
- … and advertising regulations and other regulations specific to Life Sciences/Pharma and Medical Device companies. + Perform other duties as assigned. **Required ... firm and/or in-house legal department, preferably in the Life Sciences/Pharma, Medical Device or health care field. + Solid commercial contract background with… more