- Eckert & Ziegler Isotope Products, Inc. (Valencia, CA)
- …Must be able to travel and work in Burbank and in Valencia. Experience with compliance to MDSAP, European Medical Device Directives (MDD), EU MDR/IVD, FDA, ... the Director of Quality Operations as necessary, to assure compliance with the company GMP Quality Management System program....CFR / IAEA, DAkkS / ISO 17025 , and Medical Device Directive (93/42/EEC) and Medical… more
- Exact Sciences (Madison, WI)
- …the organization. Ability to work designated schedule. Ability to work on a mobile device , tablet, or in front of a computer screen and/or perform typing for ... caregivers, a retirement savings plan, wellness support, and health benefits including medical , prescription drug, dental, and vision coverage. Learn more about our… more
- 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
- Meta (New York, NY)
- …strategic legal support and guidance on complex healthcare fraud & abuse laws, medical device compliance (FDA) requirements, and international health ... to shape Meta's approach to digital health and regulatory compliance at a global scale. As Associate General Counsel,...firm and/or in-house or government experience 11. Experience in medical device , life sciences, or healthcare industry… 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
- 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 (Annapolis, MD)
- …in regulated contexts. + Certifications in project management, cloud architecture, or medical device /healthcare compliance . Disclaimer: **Certain US customer ... and Compliance teams to ensure Oracle's healthcare solutions align with global medical device standards, including **IEC 62304, IEC 82304, ISO 13485, ISO… 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
- Globus Medical, Inc. (Methuen, MA)
- …This role requires deep expertise in precision engineering, motion systems, and medical device design, ensuring compliance with regulatory standards ... + Excellent oral, written, and graphical communication skills + Experience in the Medical Device field **Physical Demands** **:** The physical demands listed… more
- Cordis (Miami Lakes, FL)
- …Prior experience with MES implementation on multiple platforms. + Solid understanding of Pharmaceutical/ Medical Device compliance standards (21 CFR Part 11, ... of experience in MES implementation and support within the Manufacturing and Medical Device industry. **Preferred Qualifications** + Strong knowledge of Critical… more
- Teleflex (Wyomissing, PA)
- …Conduct microbiology and biology testing in support of R&D, method development, and medical device evaluation, ensuring compliance with protocols, quality ... Sciences, or related field. * 2-4 years of relevant laboratory experience ( medical device , microbiology, or related industry preferred). * Demonstrated… more
- BD (Becton, Dickinson and Company) (Columbus, NE)
- …+ Computer skills - Proficient + Working knowledge of FDA regulations & other medical device regulatory compliance requirements - Proficient + Decision ... with line operations. + Strong practical work experience (8+ years); experience in medical device , food or drug industries preferred. + Proven record of… more
- Edwards Lifesciences (Draper, UT)
- …for Metals will manage Quality Engineers that focus on supporting Metals Operations, ensuring medical device quality compliance and that controls are in ... + Six Sigma Black Belt/Lean Black Belt + Proven project management, leadership and medical device audit leader skills + Proven expertise in both Microsoft Office… 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
- Envista Holdings Corporation (Quakertown, PA)
- …Travel: Up to 10%, as needed. **PREFERRED QUALIFICATIONS:** + MS degree preferred. + Medical device design and compliance experience. + Compliance ... operations, regulatory and quality backgrounds that work collaboratively in the fast-paced medical device field. A friendly and open atmosphere helps to… more
- Bausch + Lomb (Clearwater, FL)
- …to the quality of the medical devices. The Precision Machinist ensures compliance with stringent medical device industry standards and works closely ... activities comply with Current Good Manufacturing Practices (cGMP) and relevant medical device regulations. + Ensure compliance with good documentation… more
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