- 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 ... enterprise quotes. + Understand the specialized requirements for quoting regulated medical software, hardware, and consulting; ensuring accurate compliance ,… more
- Hologic (Marlborough, MA)
- …Corrections and Removals), FDA Quality System Regulations, ISO 13485:2016, and EU Medical Device Regulation regarding field safety corrective actions. + ... with FDA Industry Guidance for Recalls and guidance on distinguishing recalls from medical device enhancements. + Understanding of MEDDEV 2.12/1 guidelines for… more
- Atrius Health (Boston, MA)
- …that lab and other test results are available in the electronic medical record (EMR). Delivers excellent customer service and strengthens the patient/clinician ... testing required for exams specific to the department. Ensures patients' electronic medical record (EMR) is updated with medical information, including recent… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Fellowship Trained Board Certification. + Minimum of 10-12 years of biotechnology/pharmaceutical/ medical device industry experience in medical affairs, ... live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care...your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential,… more
- Astrix Technology (Boston, MA)
- …field-based medical affairs role within the pharmaceutical, biotechnology, or medical device industry. + Scientific Expertise: Deep understanding of ... teams such as Clinical Development, Regulatory Affairs, and Commercial to provide medical insights that inform strategic decisions. + Compliance and Reporting:… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Company-wide patient safety expert for assigned pharmaceutical / biological / drug- device combined products, accountable for the safety strategy and major safety ... the benefit-risk profile of assigned products to senior management. + Provide medical safety expertise, medical interpretation, review, and authorship of… 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 ... is responsible for performing upgrades for Fujifilm Healthcare Americas Corporation (HCUS) Medical Informatics (MI) products to all eligible sites. In addition will… more
- Wolters Kluwer (Waltham, MA)
- …a pivotal role in driving the development and delivery of Software as a Medical Device (SaMD) products. This position is responsible for enabling engineering ... teams to operate at high velocity while ensuring strict compliance with global regulatory standards such as FDA, EU MDR, ISO 13485, and IEC 62304. They are… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …teams and the compliance committee, guiding the development of commercial and medical strategies and helping the teams manage and mitigate legal risk. + Advising ... the US Compliance Committee. + Working collaboratively across functions, including Compliance , Regulatory and Medical Affairs, to support a policy, training… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …technical discipline required + At least 5+ years of experience in a medical device or other highly regulated electro-mechanical environment required + ... innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and… more