- Oracle (Sacramento, CA)
- …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
- AbbVie (Irvine, CA)
- …both current and emerging regulations and standards impacting AbbVie medical device and combination products. + Performs regulatory compliance assessments to ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...The role serves as Deputy Person Responsible for Regulatory Compliance for assigned Device Legal Manufacturer under… more
- Oracle (Sacramento, CA)
- …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
- Stryker (San Jose, CA)
- …or similar automated test frameworks. + Understanding of FDA and ISO 13485 medical device compliance requirements. + Experience with hardware-in-the-loop ... integration. + Enjoy exposure to advanced technologies, simulation environments, and real-world medical device applications. At Stryker, one of the world's… more
- Oracle (Sacramento, CA)
- … 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
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …whenever requested by colleagues who may require assistance understanding complex rules governing medical device industry. + Ensure compliance with global ... customers alike. + Monitor changes in legislation relating to medical device industry; stay abreast of emerging...US and EU. + Conduct regular audits to ensure compliance with relevant regulations governing medical devices;… more
- RGP (Menlo Park, CA)
- …and traceability of part components through finished goods within a regulated medical device environment, ensuring compliance and operational excellence. ... Supply Chain Leader to drive critical initiatives for a medical device manufacturing organization. This role will...+ Ensure FDA, ISO and other regulatory compliance and operational readiness for commercialization. + Manage system… more
- Fujifilm (Sacramento, CA)
- …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
- Gilead Sciences, Inc. (Foster City, CA)
- …**Patient Safety Strategic Operations** team as an **Associate Director, Patient Safety Medical Device Safety** responsible for supporting activities to ensure ... complaints, risk management, and analysis of safety data sets covering Gilead medical device and combination product portfolio. This role will help drive… more
- Oracle (Sacramento, CA)
- …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