Annika Lind Email & Phone Number

Maple Grove, MN, US

Greater Minneapolis-St. Paul Area

Eden Prairie, Minnesota, United States

Greater Minneapolis-St. Paul Area

Applied my regulatory expertise to assist in business development

Greater Minneapolis-St. Paul Area

• Perform quality and fulfillment support for a virtual Class I medical device company
• IMSXpress Quality System Software Proficiency
• Followed Standard Operating Procedures (SOPs)
• Regulation (EU) 2017/745 (MDR) deep dive gap analysis work on technical files for leading medical device companies (Class IIb devices, specific areas of focus include: IFU and CER)
• Perform extensive research of clinical databases including PubMed, FDA web
• Redesign Clinical Evaluation Reports (CERs) for Class III medical devices to MDD

Carrington, North Dakota

• Performed pack audits, examined process flow of the product lines and completed product cook tests
• Collected samples of product to run die measurements and moisture analysis, inspected incoming raw product, inspected final product for damage
• Formulated processed wheat COAs for sister company in Minneapolis

Jamestown, ND

• Worked in Northern Great Plains in wind, heat, cold, rain, and hiked through tall grasses, barbed wire, electric fences and cattle to reach the plots. Worked for Battelle Ecology Inc. on the NEON (National Ecological.
• IACUC Training, implemented and revised SOPs, team environment, long hours in the field (early morning-late evening)
• Entered field data in real-time using a Mobile Data Recorder (Small Mammals, Mosquitoes, Beetles, Phenology, LAI, Clip, Diversity, Ticks)

Jamestown, North Dakota