BiologicalSafetySpecialist

## Accountabilities Develop, review, and maintain biological safety documentation and reports in compliance with applicable international standards and medical device regulations. Assess and audit biocompatibility and material characterization data to ensure alignment with regulatory requirements and safety expectations. Interpret complex scientific and technical information to support risk assessments and regulatory submissions for medical devices. Collaborate with cross-functional teams to ensure biological safety considerations are integrated throughout the product development lifecycle. Review and contribute to the development of complex technical and regulatory documents with a high level of accuracy and scientific rigor. Support continuous improvement of biological safety processes, methodologies, and compliance frameworks. Requirements: Bachelor’s degree with at least 5 years of relevant experience, or Master’s/Doctorate degree with at least 2 years of relevant experience in a scientific or related discipline. Strong knowledge of medical device regulations and international standards related to biological safety and biocompatibility. Experience assessing compliance of biocompatibility studies and material characterization against regulatory requirements. Proven ability to write, review, and manage complex technical and regulatory documentation. Strong analytical and critical thinking skills with attention to detail and scientific accuracy. Proficiency in Microsoft Word and other standard documentation tools. Fluency in English; proficiency in the local language (if different) is required. Strong communication and collaboration skills in multidisciplinary and regulated environments. Benefits: Opportunity to work at the forefront of medical device safety and regulatory science. Exposure to global standards and internationally recognized regulatory frameworks. Collaborative, science-driven work environment focused on innovation and patient safety. Professional d