- Actalent (Plymouth, MN)
- Senior Labeling Specialist Key Responsibilities: + Create, revise, and maintain labeling , including user manuals, quick-start guides, labels, and other ... technical documents. + Ensure all labeling meets applicable regulations, industry standards, and company quality policies. + Coordinate and manage the translation of… more
- Medtronic (Minneapolis, MN)
- …in Mounds View, MN but a remote worksite may be considered. The ** Senior ** **Principal Regulatory Affairs** will play a key role in providing regulatory affairs ... I, II and Class III medical devices. The Sr Principal Regulatory Affairs Specialist is responsible for activities to launching new products and sustain the current… more
- Medtronic (Minneapolis, MN)
- …and efficiently, with more predictable procedure times and outcomes. The ** Senior Regulatory Affairs Specialist ** develops strategies for worldwide product ... requirements, prepares worldwide submissions and negotiates their approval. The specialist also assists with the license maintenance including renewals,… more
- Abbott (Plymouth, MN)
- …on with their lives. **The Opportunity** Abbott is seeking a passionate, experienced ** Senior Regulatory Affairs Specialist ** to join our team on-site in ... new or modified, are distributed to appropriate personnel. + Reviews device labeling for compliance with FDA submissions and applicable regulations. + Supports the… more
- Abbott (St. Paul, MN)
- …the treatment of structural heart disease. **The Opportunity** We are recruiting for a ** Senior Regulatory Affairs Specialist ** to join our team on-site in St. ... and expand as appropriate). + Medical writing, Advertising and promotion, Labeling , Controlled substances (eg DEA), Restricted substances (eg REACH), Compendial /… more
- Cardinal Health (Roseville, MN)
- …release, facilities and equipment, material controls, laboratory controls, packaging and labeling , and production & process controls. + Establishes and reports ... metrics related products and processes as deemed necessary by the Regional Quality Manager (RQM). + Ensures the site manufactures products to meet the requirements of 21 CFR 212 (CGMP) + Handles and ensures quality of documentation (control, retention, and… more