- Sumitomo Pharma (St. Paul, MN)
- …Programming Organization. + Create/acquire tools to improve programming efficiency or quality . + Establish monitoring of data transfers for ongoing trials to ... + Ability to generate documents / files required for regulatory filing. Ex. Reviewers' Guides, Define.XML, Annotated CRFs etc....to achieve objectives in innovative and efficient ways. + FDA submission experience is a must. + Solid knowledge… more
- Insight Global (Maple Grove, MN)
- …team. This role involves ensuring that our product designs meet rigorous quality and safety standards throughout the development process. You'll collaborate closely ... Drive the creation of test protocols and reports, ensuring compliance with regulatory and industry standards. . Analyze testing data and prepare technical… more
- Post Holdings Inc. (Lakeville, MN)
- …**Manufacturing & Compliance** + Lean Manufacturing & Six Sigma principles. + Regulatory knowledge: FDA , GMP, SOX compliance. + Traceability & Serialization ... 'n Bits(R) and 9Lives(R) dog and cat food. As a company committed to high standards of quality and to our values, we are driven by one idea: To make lives better by… more
- Abbott (St. Paul, MN)
- …processes, components and products. + Work with cross-functional teams including R&D, Quality , Operations, and Regulatory teams. Collaborate with R&D to ensure ... customers, and vendors. + Comply with US Food and Drug Administration ( FDA ) regulatory requirements, Company policies, operating procedures, processes, and task… more
- Abbott (St. Paul, MN)
- …Purpose of Role** This position is responsible for the production of high quality medical device hardware and systems. This position includes detailed assembly and ... safety devices when performing all operations + Participate in continuous improvement/ quality initiatives in order to enhance production processes to achieve … more
- Teleflex (Minneapolis, MN)
- …understanding of FDA , ICH, GCP regulations governing clinical trials, standard regulatory and clinical practices, and current regulatory issues related to ... driven by our purpose to improve the health and quality of people's lives. Through our vision to become...training and mentoring of newly hired specialists. * Support quality improvement initiatives and departmental decisions. * Collaborate with… more
- Medtronic (Mounds View, MN)
- …data presentations and publications + Competitive investor relations calls and meetings + FDA and other regulatory filings and announcements + Customer feedback ... may have arrived overnight from global partners and reviews any news releases, regulatory site updates, and field reports of competitive activity. You may need to… more
- Fujifilm (St. Paul, MN)
- …systems. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... factors, which may include customer impact, HCUS business priorities, and regulatory requirements. Normally receives little instruction on day-to-day work and… more
- Abbott (Plymouth, MN)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... operations and processes. **What You'll Work On** + Performs regular process and quality performance audits of personnel, tooling, and equipment in assigned areas. +… more
- Abbott (St. Paul, MN)
- …improve processes,componentsand products. + Work with cross-functional teams including R&D, Quality , Operations, and Regulatory teams. Collaborate with R&D to ... customers, and vendors. + Comply withU.S. Food and Drug Administration ( FDA ) regulatory requirements, Company policies, operating procedures, processes, and… more