- Philips (Cambridge, MA)
- …management . + **Compiles** and **analyzes** clinical and safety data to support medical device performance in alignment with EU regulatory standards (MEDDEV ... 2.7.1 Rev. 4, EU Medical Device Regulation). + **Author** and **maintain**...Post-market Clinical Follow-up Plans/Reports, and Investigator Brochures, contributing to Risk Management and Post-Market Surveillance activities. +… more
- Olympus Corporation of the Americas (Westborough, MA)
- …product security, cybersecurity, and equipment development oversight. Extensive knowledge of medical device design control requirements, system design and ... and design for manufacturability and testability is required. Deep understanding of medical device standards, and experience in their application, is required.… more
- Fresenius Medical Center (Lawrence, MA)
- …remotely. **PURPOSE AND SCOPE** Act as a Quality Business Partner for Software as a Medical Device and Non- medical software device engineering teams to ... FDA and MDCG guidance. . Responsible for the planning and implementation of risk management , the creation and updating of the risk analysis while complying… more
- Takeda Pharmaceuticals (Boston, MA)
- …that may impact the benefit- risk profile of assigned products to senior management . + Provide medical safety expertise, medical interpretation, review, ... + At least 3 years of experience with aggregate reporting, safety surveillance, signal management and/or risk management . + Knowledge and understanding of… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …compliance issues, trends, and regulatory updates regularly to identify vulnerability, inform risk management strategies, and update practices as needed. + Work ... ensures ethical behaviors and plays a fundamental role in risk identification and mitigation by building and running an...more years in life science organizations, ideally in the medical device industry. Knowledge, Skills and Abilities… more
- Jabil (Clinton, MA)
- …the product lifecycle to enable both the growth and maintenance of our medical device product portfolio. Primary responsibilities of the role include user ... individual must have a record of success within a medical device product development environment, command of...standards as they relate to the design, manufacture, and risk assessment of medical devices - Highly… more
- Hologic (Marlborough, MA)
- …a visionary leader with a passion for ensuring the highest standards of quality in medical device design and development? We are seeking a dynamic **Director of ... Compliance** : + Promote awareness and efficacy of design control and risk management procedures/processes. + Drive continuous improvements through collaborative… more
- ZOLL Medical Corporation (Boston, MA)
- …PhD, or equivalent) is preferred. Experience : + 5+ years of clinical or medical device /pharmaceutical industry experience. Required. + 7+ years of experience in ... been trusted to protect more than 1M patients at risk of sudden cardiac death. + HFMS (https://cardiacdiagnostics.zoll.com/products/heart-failure-arrhythmia- management… more
- Fresenius Medical Center (Waltham, MA)
- …management , regulatory compliance, quality engineering and auditing in the pharmaceutical or medical device sector or related industries + Several years of ... procedures to drive continuous quality improvement. Support external quality management inspections at Fresenius Medical Care sites...with best practices in product design / design change, risk management and CAPA management … more
- ZOLL Medical Corporation (Boston, MA)
- …+ Master's Degree preferred + A minimum of five years' experience in medical device or pharmaceutical sales required + Strongly preferred successful sales ... been trusted to protect more than 1M patients at risk of sudden cardiac death. + HFMS (https://cardiacdiagnostics.zoll.com/products/heart-failure-arrhythmia- management… more