- Cardinal Health (Salem, OR)
- **_What Regulatory Affairs and Clinical Submissions contributes to Cardinal Health_** The _Manager, Regulatory Affairs ( Clinical Submissions)_ is ... or timelines. + **Leadership & Team Development** + Lead, mentor, and develop junior regulatory affairs staff, providing training and guidance on regulatory … more
- Veterans Affairs, Veterans Health Administration (Roseburg, OR)
- …and equitable patient care. Ensures compliance with accreditation and regulatory standards. Aligns nursing/ clinical objectives with organizational strategic ... Summary The Nurse Manager (NM) is the designated first-line supervisory authority...and execution. Maintains knowledge and ensures compliance with all regulatory and accreditation standards, Directives, policies, and standard operating… more
- Veterans Affairs, Veterans Health Administration (Roseburg, OR)
- …The C&P Specialist is aligned to and supervised by the C&P Manager . The incumbent ensures compliance with VHA policies, directives, memos and notices ... regarding routine and complex matters related to C&P. Assisting the C&P Manager /Analyst in developing short- and long-term goals necessary to accomplish the mission… more
- Sumitomo Pharma (Salem, OR)
- …of expiry dates and communicates changes to contract manufacturing organizations, testing laboratories, clinical sites and regulatory affairs as needed. + ... and suppliers of drug substances and drug products used for investigational clinical trials and/or commercial phases. The Senior Manager ensures compliance… more
- Edwards Lifesciences (Portland, OR)
- …our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for ... clinical trials with skill levels exceeding the requirements of the Associate Manager Required + Experience in clinical trial design, indication lead +… more
- Fujifilm (Salem, OR)
- …+ Proven track record working with Marketing, Business Development, Engineering/QA, and Regulatory Affairs . + Competitive knowledge of Medical IT and Imaging ... US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all...at least 1-2 years direct experience as a Product Manager within HCUS/MIPD + Strong understanding of clinical… more