Shand Lori Email & Phone Number | Project Coordinator IV Medtronic, Inc July 2014 - Present 4 years 8 months USA-MN Mounds View • Archive all documents sent to the EFR Mailbox: Annual Reports, FDA Correspondence, RRAs,DRAs, NPNs, PCNs not in Agile, Etc. • QC and route PCNs in Agile - Route Product Change Notifications (PCNs) and New Product Notifications (NPNs) in the Agile Product Life-cycle Management (PLM). This includes checking for completeness, reviewing, and acknowledging prior to sending the PCN/NPN to the Responsible RAS for final approval. • File approvals, renewals and Certificate of Compliance Memos in RAD and enter appropriate data into the RF Approval Database for the Radio Regulatory team. • MDUFA Fees: Create User Fee cover sheet, request and ship checks to FDA for submission fees. Enter all pertinent information into tracking system. • Set up Regulatory Operations department meetings, assist in coordinating other team events. • Order supplies needed for submissions.

Shand Lori

Project Coordinator IV Medtronic, Inc July 2014 - Present 4 years 8 months USA-MN Mounds View •...
Minneapolis, Minnesota, United States

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Shand Lori’s Location Minneapolis, Minnesota, United States

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Project Coordinator lV

2014-07-01 00:00:00 - Present

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Shand Lori is a Project Coordinator IV Medtronic, Inc July 2014 - Present 4 years 8 months USA-MN Mounds View • Archive all documents sent to the EFR Mailbox: Annual Reports, FDA Correspondence, RRAs,DRAs, NPNs, PCNs not in Agile, Etc. • QC and route PCNs in Agile - Route Product Change Notifications (PCNs) and New Product Notifications (NPNs) in the Agile Product Life-cycle Management (PLM). This includes checking for completeness, reviewing, and acknowledging prior to sending the PCN/NPN to the Responsible RAS for final approval. • File approvals, renewals and Certificate of Compliance Memos in RAD and enter appropriate data into the RF Approval Database for the Radio Regulatory team. • MDUFA Fees: Create User Fee cover sheet, request and ship checks to FDA for submission fees. Enter all pertinent information into tracking system. • Set up Regulatory Operations department meetings, assist in coordinating other team events. • Order supplies needed for submissions.