At B. Braun, we are looking for a biocompatibility expert to join the R&D department (medical devices)  at our site in Rubí.

Would you like to be part of a committed team passionate about knowledge and challenges? Do you want to work in a learning and cooperative environment? Do you want your work to contribute to improving patients' lives?

Functions

• Preparation of evaluation plans, biological risk reports, and toxicological risk assessments in accordance with ISO 10993-1, ISO 10993-17, and ISO 14971, for submission to European Notified Bodies, FDA, NMPA, PMDA, and other international regulatory agencies.
• Evaluation of biocompatibility and general toxicology data, ensuring compliance with applicable regulatory requirements and standards, and confirming that studies meet the latest requirements.
• Assessment of the biological relevance of unexpected results in biocompatibility testing.
• Conducting literature searches and summarizing findings.
• Performing biocompatibility gap analyses when regulations are updated, and drafting clear and concise reports on their impact.
• Liaising with certified external providers for the execution of biocompatibility tests.
• Participating in the definition and organization of biocompatibility tests carried out by certified external providers.
• Reviewing protocols and reports of biocompatibility tests conducted by certified external providers.
• Preparing response strategies to competent authorities in regulatory processes related to biocompatibility and material characterization.
• Participating in the definition and review of procedures and methodologies related to biocompatibility and material characterization.
• Providing support and advice to R&D staff as a subject matter expert on technical issues related to biocompatibility and material characterization.
• Delivering training on biocompatibility topics, including applicable standards and regulations, to R&D staff.
• Regularly attending courses, proactively ensuring that training is adequate for the responsibilities associated with the position.

Requirements

• Degree in Life Sciences.
• 3 to 5 years of prior experience in similar roles is essential.
• Practical knowledge of FDA, EU MDR, and other global medical device and/or biological regulations, ISO 10993 and 14971 series.
• Training in medical device biocompatibility.
• Specific training in toxicology will be valued.
• Full professional proficiency in English.

Personal Competencies

• You are responsible, committed, and willing to contribute to objectives.
• You think logically, analytically, and systematically, and are motivated by complex problems and tasks requiring high-level critical thinking.
• You are organized and know how to plan to meet deadlines, pursuing quality standards appropriate to the goal.
• You have excellent communication skills.
• You are a good team player and willing to integrate into a high-performance team.
• You adapt to change and are open to developing new skills to face challenges.
• You have a positive attitude toward challenges.
• You are enthusiastic about knowledge and motivated by autonomous learning.

If you believe your experience and professional interests are align with this opportunity, we encourage you to apply, we want to hear from you!

B. Braun Surgical, S.A.U. | Victoria Merodio