- Medtronic (Minneapolis, MN)
- …develop solutions to complex US promotional issues. + Interact directly with FDA and/or indirectly with international regulatory agencies on most ... life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with...feedback and on-going support to product development teams for regulatory issues and questions. + Prepare FDA ,… more
- Philips (Plymouth, MN)
- …new product development projects, ensuring our state-of-the-art Ultrasound Products meet FDA , and other governmental agency/notified body Regulatory Compliance ... if:** + You have a minimum of 8+ years' Regulatory Affairs experience within FDA regulated Medical...stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of… more
- Abbott (Plymouth, MN)
- … affiliates. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Interfaces directly with FDA and other regulatory ... regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, Company policies,… more
- Abbott (Plymouth, MN)
- …communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other ... Abbott is a global healthcare leader that helps people live more fully...to support Abbott customers. + May interface directly with FDA and other regulatory agencies if so… more
- Philips (Plymouth, MN)
- …on time. + Your skills include extensive knowledge and authoring of FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), Technical ... **Director, Regulatory Affairs- Software and Artificial Intelligence (Ultrasound)** The...proactive, strategic relationships with external stakeholders (notified Bodies, US FDA , Competent Authorities, etc.) to ensure that requirements are… more
- Sumitomo Pharma (St. Paul, MN)
- …and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and ... highly motivated, and experienced individual for the position of Senior Manager, Regulatory Operations, For assigned projects, the Senior Manager of Regulatory … more
- Philips (Plymouth, MN)
- …right fit if:** + You've acquired 10+ years of experience working in Regulatory Affairs and Quality/Quality Operations within the FDA regulated Medical Device ... The Director, Regulatory Affairs will lead the Philips RespirTech InCourage...making. Build proactive, robust, strategic relationships with external stakeholders ( FDA , NBs, CAs, MedTech forums etc.) to influence and… more
- Sumitomo Pharma (St. Paul, MN)
- …+ Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … more
- Otsuka America Pharmaceutical Inc. (St. Paul, MN)
- …(eg, clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Grifols Shared Services North America, Inc (Minneapolis, MN)
- Would you like to join an international team working to improve the future of healthcare ? Do you want to enhance the lives of millions of people? Grifols is a global ... healthcare company that since 1909 has been working to...110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development,… more