Natalia Z.
- Role
- Medical Writer Ii at Abbott
- Location
- Chicago, IL, US
- LinkedIn followers
- 500 followers
About Natalia Z.
I believe in looking for different ways of doing things. “That’s how we’ve always done…
Experience
Medical Writer Ii
Jun 2019 — Present
Proficient in technical writing for test records, International Product Master File/Technical File (IPMF/TF) chapters, troubleshooting guides, and labeling (IFUs and product labels) for new product regulatory submission and on-market product maintenance, while following established formatting/styles guidelines.• Coordinate data compilation into a comprehensive package for the regulatory submission of assays and medical device products.• Arranges and conducts cross functional review meetings regarding submission and technical files; communicates resource needs to team members and act as a liaison to all functional teams• Assembles, authors, and verifies product submissions, ensuring consistency regulatory guidelines and completeness of information.• Achieved approval on CE Mark and 510(k) submission for Clinical Chemistry assays,
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