- 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
- Children's Hospital Boston (Boston, MA)
- … device manufacturer and FDA hazard alerts and recalls. + Tracks medical device regulatory compliance , including input on policies and procedures. ... areas throughout the Boston Children's Hospital organization related to: medical device technology planning, implementation, and operationalization; complex… more
- J&J Family of Companies (Danvers, MA)
- …or Project Management preferred + Minimum 4 years of experience supporting medical device studies. + Prior Compliance /Quality experience preferred. ... **We are searching for the best talent for a** Manager, Global Clinical Compliance . This is a remote role available in the continental USA. **Purpose:** The… more
- Caldera Medical (Westlake Village, CA)
- …and provide regulatory input and guidance to cross-functional partners regulatory documentation for medical device approvals in compliance with EU MDR, ... your role as a Sr. Regulatory specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide… 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
- 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
- 3D Systems, Inc. (Littleton, CO)
- …* Medical Device Knowledge*- Exposure to FDA regulations, ISO 13485, and medical device compliance * *Core Skills*- Human anatomy knowledge, Microsoft ... a state-of-the-art, fast-paced work environment that specializes in creating patient-specific medical tools derived from advanced medical imaging technologies.… more
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