Senior Research Associate (Biocompatibility Subject Matter Expert)Req # JR - 005644 Location Marsa, Il-Marsa, Malta Job Category Research and Development Date posted 12/27/2019
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- Study Monitor / Study Director of Biocompatibility Studies to qualify medical devices and / or containers in accordance with ISO 10993-1 and / or USP or EP Pharmacopeia
- Knowledgeable in biocompatibility standards and requirements
- Effectively collaborate with team members from various disciplines globally to develop biocompatibility testing strategies to qualify materials used in Baxter products.
- Work closely with Senior Manager to determine potential regulatory risks associated with proposed biocompatibility test strategy and reviewing junior team members protocols / reports.
- Knowledge of biocompatibility requirements for medical devices in accordance with ISO 10993, USP <87>, USP <88> and global compendia guidance’s for medical devices and container closure systems
- Global cross-collaboration with Biocompatibility team members for alignment with testing strategies
- Serve as biocompatibility subject matter expert for developing test strategies, authoring Biocompatibility narratives for US FDA 510 K Submission and CE Mark
- Serve as point of contact for interactions with regulatory bodies related to available biocompatibility data supporting a product
- Generate study plans to describe proposed biocompatibility testing strategy, monitor biocompatibility studies at external contract laboratory, review reports generated by external contract laboratory, and generate a final summary report
- Work with junior team members in assisting with developing biocompatibility strategies as well as reviewing junior team members study plans and final reports.
- 3-5 years experience
- Bachelors Degree in Biological Sciences or Toxicology
- Excellent oral and written communication skill
- Attention to details
- Critical thinking skills to Interpret available information and make recommendations to resolve technical challenges.
- Appropriately prioritize assignments to meet project schedules.
- Fluent in English, Spanish, and /or French
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.