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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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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.


  • 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.


  • 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 and let us know the nature of your request along with your contact information.

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