- Takeda Pharmaceuticals (Lexington, MA)
- …continuous improvement of operations and quality systems for medical device and digital health technologies, ensuring compliance with international ... devices, combination products, in vitro diagnostics (IVDs), and Software as a Medical Device (SaMD), ensuring compliance with global quality standards. +… more
- Oracle (Boston, MA)
- …needs. + Regulatory Compliance & Quality Alignment + Ensure adherence to medical device software standards including IEC 62304 (software lifecycle) and IEC ... governance, and scalable design patterns across the organization's medical device portfolio. + Identify opportunities to streamline compliance activities… more
- Oracle (Boston, MA)
- …In addition, this role will help ensure **operational alignment with international compliance frameworks and medical device regulatory requirements** as ... & Certification:** Collaborate with legal, regulatory, and product stakeholders to support ** medical device certification and compliance activities** as HDI… more
- Oracle (Boston, MA)
- … programs, policies, training and monitoring. + Experience with Software as a Medical Device marketing and promotion compliance requirements. + Experience ... bar by demonstrated behavior and outcomes. + Strong knowledge of global healthcare compliance requirements applicable to medical device and digital health… more
- J&J Family of Companies (Danvers, MA)
- …Master, or equivalent project management certifications. + Domain-specific certifications (eg, medical device software compliance , automotive safety ... Engineering, or related field. **Experience:** + 10+ years in embedded software development in medical device domain. + 4+ years in a leadership or managerial… more
- Takeda Pharmaceuticals (Lexington, MA)
- …best of my knowledge. **Job Description** **About the Role** As Head of Global Quality Device Compliance for the US and Rest of World region, you will provide ... medical devices, including stand-alone devices, combination devices, and Software as a Medical Device (SaMD). You will ensure that Quality System requirements… more
- Nanobiosym, Inc. (Cambridge, MA)
- …+ Solid understanding of secure firmware update protocols and architecture. + Experience with medical device compliance and documentation as per FDA and ... communicate clearly with team to document designs, review code, and ensure compliance with security and performance guidelines. Qualifications: + Essential: + Proven… more
- Fujifilm (Boston, MA)
- …to be an integral part of the legal team providing support to the Medical Device businesses of FUJIFILM Healthcare Americas Corporation and FUJIFILM SonoSite, ... responsible for working independently and collaboratively on legal issues affecting the Medical Device businesses to minimize risks of legal liability and… more
- Oracle (Boston, MA)
- …patient safety, usability, and compliance across our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager ( Medical ... is standing up a specialized clinical product management team focused on medical device -aligned products. This team bridges clinical practice, product strategy,… more
- Oracle (Boston, MA)
- …patient safety, usability, and compliance across our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager ( Medical ... is standing up a specialized clinical product management team focused on medical device -aligned products. This team bridges clinical practice, product strategy,… more