Research Associate Senior

看过: 135

更新日: 26-11-2025

位置: Wavre Walloon Brabant

类别: 执行管理

行业:

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工作内容

This section focuses on the main purpose of the job in one to four sentences :

Execute biocompatibility testing strategies for our client’s medical device portfolio for EU MDR submission purposes according to global guidelines.
Coordinate biocompatibility testing globally at Contract Research Organizations.
Maintain an in-depth knowledge and understanding of global guidelines utilized in biocompatibility study designs.

What you’ll do

Work cross-functionally with internal partners at all levels (technicians, scientists, engineers and management) and external laboratories
Coordinate biological safety testing for Baxter’s Renal Care/Acute Therapies medical device product portfolio, specifically for EU MDR regulatory submission purposes
Perform as Study Monitor/Study Director for biocompatibility studies
Utilize global database for material management
Attend project meetings, provide time estimates for projects, and proactively track project progress
Use knowledge and understanding of ISO10993-1, regional pharmacopeia, International Conference of Harmonization (ICH), 21 CFR Part 58 Good Laboratory Practices for Nonclinical Laboratory Studies (GLP), and other regulatory guidance’s

Profile

Bachelor’s degree with 5-7 years’ experience or 3-5 years’ experience with Masters and 0-3 years’ experience with PhD.
Solid knowledge of global regulatory guidelines including ISO10993, global guidelines and 21 CFR Part 58 (GLP)
Experience in working in global cross functional teams and project management
Experience of coordinating medical device biocompatibility studies
Fluent in English (spoken and written)

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