- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... of up to 3 Tesla, which could dangerously affect any implanted medical devices made of ferrous material, potentially causing serious injury and/or death.… more
- Astrix Technology (Boston, MA)
- …field-based medical affairs role within the pharmaceutical, biotechnology, or medical device industry. + Scientific Expertise: Deep understanding of ... Collaboration: Work closely with internal teams such as Clinical Development, Regulatory Affairs, and Commercial to provide medical insights that… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... of up to 3 Tesla, which could dangerously affect any implanted medical devices made of ferrous material, potentially causing serious injury and/or death.** +… 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 market, preferably selling diagnostic imaging equipment or related peripheral devices into the surgical space. Educational Requirements + BA/BS required.… more
- Fresenius Medical Center (Waltham, MA)
- … regulatory compliance, quality engineering and auditing in the pharmaceutical or medical device sector or related industries + Several years of practical ... in compliance with FME policies and procedures and applicable regulatory requirements + Develop and maintain audit processes and...preferred) + Knowledge of current regulations for pharmaceutical and medical devices (eg, 21 CFR Part 820,… more
- Hologic (Marlborough, MA)
- …ensure our medical devices , particularly those involving Software as a Medical Device (SaMD), are safe, effective, and compliant with regulatory ... Responsibilities:** + Apply extensive knowledge of **Software as a Medical Device (SaMD)** , including its design,...expertise in **AI software** applications within medical devices to ensure compliance with regulatory standards… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... Cardiovascular opportunities. + Develops effective business partnerships with the Medical Informatics marketing team, Solutions Delivery and Support Department,… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... of experience with a Master's degree. + Minimum 8 years of medical device industry experience in a clinical capacity (clinical demonstration and education) with… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... with Key Accounts and Opinion Leaders within the Liver/Hepatology Medical Oncology community. Manage specific assigned geographic areas and successfully… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... Healthcare Americas Corporation's (HCUS) full portfolio (Endoscopy, Modality Solutions, and Medical Informatics) to key Federal Government medical treatment… more
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