Jeme Ertl

Regulatory Affairs Program Manager - Digital Strategy @Olympus Corporation

Chicago, IL, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jan 2024 — Present

Regulatory Affairs Program Manager - Digital Strategy @Olympus Corporation

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Chicago, IL, US

EDUCATION

N/A

Andrews University

Medical Technology, Clinical training in Medical Technology

N/A

University of Denver

B.S. - Biological Sciences, Biology, Chemistry

2020 — 2021

Loyola University Chicago School of Law

Master of Jurisprudence, Health Law

SKILLS

Iso 13485FdaMedical DevicesCapaRegulatory Affairs

ABOUT JEME ERTL

I am a Regulatory Affairs professional with experience in medical device and IVD regulations. I have worked in medium and large multinational companies collaborating with hardware and software product development teams to develop and license products in global markets. I am a dedicated manager of regulatory affairs professional teams, mentoring individuals for individual and team growth. One of my primary business goals is to always foster communication across cross-functional business teams in order to increase understanding of global licensing requirements. This assists product teams in developing a timely go-to-market strategy.I have worked with teams developing:Medical laboratory test instrumentationApheresis devices for collection of plasma, red cells, platelets, white cells, stem cellsInfusion pumpsInfusion setsHospital beds, Patient lifts, stretchersSoftware medical devices for Imaging, Fetal-maternal monitoring, Operating roomsSoftware utilizing machine learning and artificial intelligenceData connectivity software for patient care devicesLinkedIn: Can You Connect with Me? Reach out to me on LinkedIn or email me at j••••••••@gmail.com.

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Jeme Ertl — Regulatory Affairs Program Manager - Digital Strategy at Olympus Corporation in Chicago, IL, US | Unifers