- Cardinal Health (St. Paul, MN)
- **_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
- Medtronic (Minneapolis, MN)
- …in a more connected, compassionate world. **A Day in the Life** The ** Regulatory Affairs Specialist** is responsible for developing strategies for worldwide ... prepares worldwide submissions and negotiates their approval with the agencies. The Regulatory Affairs Specialist is responsible for assessment of device changes… more
- Danaher Corporation (Chaska, MN)
- … studies which follow GCP and FDA requirements. This position is part of the Clinical Affairs organization and will be an onsite position in either Chaska, MN ... that address the world's biggest health challenges. The Senior Clinical Data Manager for Beckman Coulter Diagnostics...performing close out audits. + Serve as liaison with Clinical Affairs to ensure robust data transfer… more
- Medtronic (Minneapolis, MN)
- …as well as other cross-functional stakeholders (eg, Research and Development, Corporate Biostats, Regulatory Affairs , Clinical IT, and others). The Principal ... complex clinical studies/projects in compliance with applicable clinical and regulatory standards and in alignment...computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions… more
- Sumitomo Pharma (St. Paul, MN)
- …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
- Abbott (St. Paul, MN)
- …colleagues to shape customer requirements for related products. + Engages proactively with Clinical Affairs , Product Development, and Regulatory to build ... executing and managing implementation of data collection efforts in partnership with clinical affairs and development and execution of competitive intelligence… more
- Rhythm Pharmaceuticals (Minneapolis, MN)
- …As a member of the Rhythm field-based North America Region team, the Sr. Manager , Field Medical will serve as a trusted scientific partner to the medical/scientific ... background as the individual will be a credible source of clinical /scientific data to Key Opinion Leaders (KOL), practicing clinicians, professional societies,… more
- Edwards Lifesciences (St. Paul, MN)
- …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 (St. Paul, MN)
- …+ 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
- Bio-Techne (Minneapolis, MN)
- …understanding of quality associated SOPs. Collaborates with Quality Assurance and Regulatory Affairs on validation summaries and reports. Maintains ... and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers… more
- CSL Plasma (Minneapolis, MN)
- …Staff Associates for completion of training and recommendation for certification by Regulatory Affairs . Functionally directs the Center Medical Staff. Provides ... appropriate physician the duties of "laboratory director", "technical consultant", or " clinical consultant" as prescribed by the Clinical Laboratory Improvement… more