- Sumitomo Pharma (St. Paul, MN)
- …**Job Overview** We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in clinical pharmacology, ... department, provide PK, PK/PD, clinical pharmacology and drug-metabolism expertise to project teams. + Design clinical pharmacology components of clinical studies. +… more
- Medtronic (Mounds View, MN)
- …Work will generally be self-directed but will be reviewed by the Manager at key time points. **Peripheral Vascular Health Operating Unit** Peripheral Vascular ... projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards.… more
- Medtronic (Minneapolis, MN)
- …including involvement with regulatory submissions, interactions with regulatory agencies (eg, FDA and PMDA), and working with cross-functional project teams. ... regulatory strategies/plans and worldwide compliance requirements. Provide on-going support to project teams for regulatory issues and questions. Find, interpret and… more
- Medtronic (Mounds View, MN)
- …multiple projects and prioritize tasks on day by day basis to meet project schedules + Interface with engineering, quality, clinical, marketing, and other functions ... to work hybrid for this role + Knowledge of FDA and EU MDR requirements + Experience of working...requirements and standards + May have practical knowledge of project management + Systems Knowledge such as RA systems,… more
- Fujifilm (St. Paul, MN)
- …on systems within a service area as directed by the Area Service Manager . **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to ... Performs other duties as assigned by the Area Service Manager . + Comply with all applicable US Food and...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- Balchem (Faribault, MN)
- …The Senior Scientist Particle Engineering will be called on to act as a Project Manager /Technical Project Leader on new product development and support ... oral. + Ability to lead cross-functional teams as a Project Manager and deliver results on time...works to ensure product compliance with regulatory bodies like FDA . + Be able to travel up to 10-20%… more
- Olympus Corporation of the Americas (Brooklyn Park, MN)
- …of the technical development schedule and monitors advancement in collaboration with the Project Manager . + Reports advancement to Core Team and to R&D ... Units, with successful product launches over time and as project demands warrant. The Staff R&D Engineer will lead...processes. + Experienced in providing technical updates to R&D manager , and/or to an R&D Core Team Member, through… more
- Medtronic (Minneapolis, MN)
- …Senior Quality Systems Specialist, you will ensure compliance with Medtronic policies, FDA regulations, ISO 13485, and other requirements. You also will provide ... are maintained and modified per periodic review requirements or project needs. + Work cross-functionally to provide guidance on...experience, with knowledge of ISO 13485, EU MDR, and FDA CFR preferred + Experience with CAPA and Root… more
- Olympus Corporation of the Americas (Brooklyn Park, MN)
- …customer service, reduce costs). + Partner with Supply Chain Operations Analyst to project manage OSTA POR requirements. + Schedule and chair meetings on POR ... Documentation Practices based on OSTA QSR documents, ISO 13485, FDA 21 CFR 820. + Meet deliverable, support and...ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential, together.**… more
- Olympus Corporation of the Americas (Brooklyn Park, MN)
- …**Job Duties** + Drive the design & execution of Production Release Process project for components & finished devices + Lead and implement complex projects including ... 5 years of experience in Quality Engineering within an FDA regulated medical device manufacturing environment. + Strong working...ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States… more