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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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Summary:

  • 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.

The Job:

  • 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.

Qualifications:

  • 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

Reasonable Accommodations

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.

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