- Vanderbilt University Medical Center (Nashville, TN)
- …meet all requirements. . The VUMC Laboratory Quality Management Department is in need of an FDA Regulatory Affairs Manager to join the team! **This ... Administration **Job Summary:** Leads VML's responses to the recent FDA LDT regulations. Develops a team to support our...identifies ways to resolve them. - Fulfills Safety and Regulatory Requirements: Understands all aspects of providing a safe… more
- Cardinal Health (Nashville, TN)
- **_What Regulatory Affairs and Clinical Submissions contributes to Cardinal Health_** The _Manager, Regulatory Affairs (Clinical Submissions)_ is ... including INDs, NDAs, BLAs, CTAs, and other filings to regulatory authorities ( FDA , EMA, etc.). + Manage...& Team Development** + Lead, mentor, and develop junior regulatory affairs staff, providing training and guidance… more
- Sumitomo Pharma (Nashville, TN)
- …a dynamic, highly motivated, and experienced individual for the position of **Senior Manager , Medical Affairs Technology and Digital Innovation** . **Job Duties ... Supports the development, implementation, execution, and oversight of Medical Information/Medical Affairs digital services and innovative digital projects as well as… more
- Sumitomo Pharma (Nashville, TN)
- …changes to contract manufacturing organizations, testing laboratories, clinical sites and regulatory affairs as needed. + Responsible for compliance with ... us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** The Senior Manager of GMP Quality Control oversees GMP compliance of… more
- Vanderbilt University Medical Center (Nashville, TN)
- …patient care, education, and research. **Organization:** VICTR **Job Summary:** Clinical Trials Manager - VICTR - Vanderbilt Coordinating Center (VCC) JOB SUMMARY In ... your pivotal role as a Clinical Trials Manager , you will be supporting the design and conduct...management, site engagement and support, monitoring planning and execution, regulatory documentation, data cleaning activities and close-out. + Ensures… more
- Fujifilm (Nashville, TN)
- …+ Proven track record working with Marketing, Business Development, Engineering/QA, and Regulatory Affairs . + Competitive knowledge of Medical IT and Imaging ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements… more
- Edwards Lifesciences (Nashville, TN)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more