- Philips (Eagan, MN)
- …detailed written regulatory plans that can be used to support international regulatory submissions and global product sales. + Develop and prepare product ... The Senior Regulatory Affairs Program Manager will play...design process and manufacturing procedures to maintain quality and regulatory compliance. + Reporting to the Head… more
- Medtronic (Minneapolis, MN)
- …Report (CER) + Risk management file and IFU development + Supports global regulatory submissions + Data and Results Interpretation: + Oversees data collection, ... In this exciting role as a Clinical Research Program Manager , you will have primary focus responsibility to develop... strategies to obtain timely product approvals form worldwide regulatory bodies. + Ensures regulatory submissions… more
- Edwards Lifesciences (St. Paul, MN)
- …quality, RA) or external review (Clinical Endpoints Committee), as well as for regulatory submissions . + Provide input into safety sections of study protocols, ... regulatory submissions , and clinical/ regulatory reports,...pathology and physiology + Expert understanding of principles of regulatory requirements and adverse events reporting +… more
- Bausch + Lomb (St. Paul, MN)
- …planning, protocol development, case report form (CRF) development, IRB submissions , investigator agreements, informed consent form (ICF) development, site selection ... trials to facilitate compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during all… more
- Robert Half Finance & Accounting (Eagan, MN)
- … submissions of tax returns and 1099 forms, meeting all legal and regulatory requirements. * Conduct ad hoc reporting and analysis as required, providing ... Description We are offering an exciting opportunity for an Accounting Manager /Supervisor based in Eagan, Minnesota, United States. The selected candidate will play a… more
- Medtronic (Mounds View, MN)
- …analysis and interpretation of data, and preparation of relevant sections of regulatory submissions , reports, and manuscripts. Work will generally be ... as needed and ensures interpretation of statistical and clinical findings in regulatory submissions , reports, and manuscripts accurately reflect the data… more
- Sherman Associates, Inc. (Minneapolis, MN)
- …FUNCTIONS + Auditing process will consist of a thorough review of all regulatory compliance records in accordance with state, federal and local regulations + Program ... Prepares compliance reports to present to the Compliance Portfolio Manager , Management and the Senior leadership team + In... on site, assumes primary responsibility for the program reporting to funders on a monthly, quarterly, semi-annual or… more