- 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
- Hologic (Newark, DE)
- …(spectrum analyzers, vector network analyzers, signal generators). + Strong understanding of medical device compliance and safety standards, device ... Engineer, R&D Newark, DE, United States **Hologic** is a global leader in medical device innovation, dedicated to improving lives through advanced technology and… more
- Community Health Systems (Franklin, TN)
- …as well as processes and methodologies for metrics and KPIs related to medical device /IoMT protections, security and compliance . + Provide technical ... **Job Summary** As a Medical Device and IoMT Security Specialist, this role reports to the Manager of Endpoint Security. This role develops, engineers, and… more
- Insight Global (Indiana, PA)
- …teams and enforce agile principles * Regulatory Awareness: Strong knowledge of medical device compliance standards and documentation requirements ... team globally. This role focuses on Software in a Medical Device (SiMD), Software as a ...○ Deep understanding of software architecture, development processes, and compliance for medical devices ○ Preferred: Qt,… more
- PDS Tech Commercial (Gainesville, FL)
- …complex projects + Knowledge of regulatory expectations for biological safety and medical device compliance **Preferred Qualifications:** + Advanced degree ... + Applying **Quality System, Federal, and International standards** relevant to medical device manufacturing and biological safety. **What You Bring**… more
- Oracle (Augusta, ME)
- …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 (Des Moines, IA)
- …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 (Olympia, WA)
- … 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
- Community Health Systems (Fort Wayne, IN)
- …all Biomedical Services fiduciary results for the assigned facilities. Responsible for all medical device required regulatory compliance for the assigned ... sustains relationships with facility staff and vendors. + Manages Medical Device Life-Cycle. + Works with the...quality and overall efficiencies. + **Quality Assurance and Regulatory Compliance ** + Ensures compliance with all relevant… more