- Integra LifeSciences (Plainsboro, NJ)
- … Medical Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies. **Primary responsibilities are:** ... patient outcomes and set new standards of care. The **Sr.** **Quality Engineer - Medical Device / Pharma** will provide Plant Quality compliance support for the… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …development lifecycle of an off the shelf, or an internally designed platform medical device delivery system. + Defines detailed product requirements and ... equivalent combination of education and experience Previous experience in combination product/ medical device development or similar area is required. Experience… more
- Gilead Sciences, Inc. (Foster City, CA)
- …robust design control and risk management practices** are followed across all device programs, in alignment with global regulatory requirements (eg, FDA, ... together. **Job Description** We are seeking a dynamic and people-focused Director of Device Development to lead a team of engineers in the design and delivery… more
- Abbott (Santa Clara, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... The individual will interact with multiple internal cross-functional teams, including R&D, medical affairs, regulatory affairs and finance to set the overall… more
- Abbott (Pleasanton, CA)
- …experience in a Quality, Regulatory , or product development role in the medical device industry. + 5+ years' experience managing a team of technical/quality ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …8 years of regulatory affairs experience within the pharmaceutical or medical device industries, ideally with expertise in drug- device combination ... **Job Description Summary** As Regulatory Affairs Associate Director, you will be responsible...strong and respected voice. + Comprehensive knowledge of US medical device regulations (FDA), Clinical Practice standards,… more
- Kelly Services (South San Francisco, CA)
- …Experience: 5+ years of regulatory experience in IVD, companion diagnostics, medical devices (Preferred experience: 7+ years of pre-market regulatory ... global RA department. + Seeks expert advice and develops device regulatory product strategies and identifies data...laboratory automation and software / hardware components of IVD medical devices . + Strong communication skills, both… more
- Aerotek (Irvine, CA)
- ** Medical Device Assemblers** **Job Description** + Join a dynamic team as a 1st or 2nd Shift Assembler, where you will play a crucial role in assembling and ... testing medical devices . + This position involves contract-to-hire...primarily catheters. + High School Diploma or Equivalent. + Medical device assembly experience. + Experience in… more
- Lilly (Indianapolis, IN)
- …(SME) Oversight** : + Demonstrate a strong ownership and stewardship for medical device design, manufacturing, labelling, and/or packaging processes you support ... by being flexible, proactive and involved. + Liaise with regulatory function to align on strategies for new products,...agendas. Understand key regulations and their impact to the medical device design transfer and post-launch surveillance… more
- Abbott (Alameda, CA)
- …+ Work closely with in-country regulatory representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies in the ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
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