- 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 (Salt Lake City, UT)
- …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
- Mallinckrodt Pharmaceuticals (Dallas, TX)
- …warehouse, distribution and delivery. Essential Functions + Performs required medical device service and maintenance in compliance with quality systems and ... Job Title Medical Device Service Technician Requisition JR000015587 Medical Device Service Technician (Open) Location Dallas, TX Additional Locations Job… more
- Oracle (Harrisburg, PA)
- …outcomes. The Senior Compliance Manager provides guidance to cross-functional teams on medical device quality system compliance , with a focus on quality ... processes and requirements under the EU Medical Device Regulation (EU MDR). **Responsibilities** The Senior Compliance...risk management, and post-market surveillance for medical device market access. The Senior Compliance Manager… 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
- AbbVie (North Chicago, IL)
- …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
- Motion Recruitment Partners (Lake Forest, CA)
- …have Requirements:** + Minimum Education and Experience:: + BS + 3+ years in medical device products safety compliance , and/or fully accredited test labs ... Working knowledge of ISO 14971 Risk Management for Medical Devices in medical device products safety compliance , and/or fully accredited test labs. + DHF… 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
- 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 ... + Experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device industry or equivalent work experience based… 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
- 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
- Hologic (Marlborough, MA)
- …and project leadership. Maintains and employs extensive integrated knowledge of products, Medical Device Quality Regulations, Compliance and Safety. Promotes ... Devices-820 Quality System Regulation, especially Design Control requirements, ISO 13485 Medical Device Quality Management System, ISO 149721:2019, Risk… more
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