- 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
- Globus Medical, Inc. (Audubon, PA)
- …**:** + Bachelor's degree combined with at least 2-3 years of healthcare compliance experience with a medical device or pharmaceutical company. ... Summary** **:** The Compliance Specialist contributes to strengthening the Globus Medical Compliance Program by promoting compliance with relevant laws,… 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
- 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
- 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 (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
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