- Olympus Corporation of the Americas (Westborough, MA)
- …(IFUs). + This includes labeling for both clinicians and patients that accompany medical device products that conform to the Olympus documentation and quality ... as part of the compliance with requirements from the European Union (EU Medical Device Regulation). + Deliver supporting documentation to the labeling product,… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... meetings when requested. + Works intimately with the FMIS development team to ensure that the product workseffectively and...experience as a Technical, Systems, Software or Quality Assurance Engineer in Medical IT and/or Imaging products.… more
- Medtronic (Boston, MA)
- …BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME_ + Bachelor's degree + 10 years medical device sales or 10 years total sales experience with a minimum of ... sales experience in capital equipment sales, surgical sales, and in-hospital pharmaceutical. Medical device sales is especially preferred but not required. +… more
- Fresenius Medical Center (Lexington, MA)
- …across the organization. + Provide planning and project management support for biomedical device product launches. + Assist in the development of marketing plans ... Associate Product Manager, Fresenius USA Marketing, Inc. a Fresenius Medical Care NA Company, Lexington, Massachusetts (Remote) Responsible for applying biomedical… more
- Medtronic (Mansfield, MA)
- …with 2+ years of experience in regulatory affairs **Nice to Have** + 4+ years of medical device regulatory affairs experience + Local to CO and willing to work ... experience with Quality Management Systems (QMS) + Technical Writing + International medical device regulatory submission/approval experience, to include FDA and… more
- Medtronic (Boston, MA)
- …degree preferred. + Experience: Minimum of 7 years relevant experience in medical device , sales, clinical service or education. **Preferred Qualifications** + ... in sales, marketing, training, healthcare, technical services or related areas in the medical device industry + Solid understanding of regulatory compliance +… more
- Hologic (Marlborough, MA)
- …Industry Experience:** Experience in software development and verification within the medical device industry is preferred. **Experience:** 6+ years in: + ... Experience with medical information system administration and extensive knowledge of medical device security standards and regulations such as FDA Premarket… more
- Medtronic (Boston, MA)
- …- DESIRED/PREFERRED QUALIFICATIONS:** + Thorough working knowledge of medical terminology, medical procedures and the medical device industry + Excellent ... world. **A Day in the Life** Bring your talents to a leader in medical technology and healthcare solutions. Rooted in our long history of mission-driven innovation,… more
- Philips (Cambridge, MA)
- …of 10+ years' experience in Quality Assurance/Engineering, within FDA regulated medical device environments, with proven functional leadership experience and ... Control and verification of effectiveness. + You have In-depth knowledge of global medical device regulations (FDA, ISO 13485, MDR), industry standards and… more
- Medtronic (Billerica, MA)
- …work experience. **Preferred Qualifications: Nice to Have** + Experience in a medical device , biotech, or pharmaceutical setting. + Familiarity with GMP, ... **Billerica, MA** site - a key location supporting the development and production of life-saving medical devices....We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission,… more
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