Biological Safety Specialist
This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Biological Safety Specialist based in Ireland.
This role sits at the intersection of science, regulation, and medical device innovation, ensuring that products meet the highest standards of biological safety throughout their development lifecycle. You will contribute directly to the safety and compliance of medical technologies that impact patient health globally. Working within a highly specialized and regulated environment, you will evaluate scientific data, assess biocompatibility, and support the creation of critical regulatory documentation. The position involves close collaboration with multidisciplinary teams and external stakeholders to ensure alignment with international standards. You will play a key role in shaping safety assessments that influence product approval and market readiness. This is a detail-driven and impact-focused role suited for professionals passionate about science, compliance, and healthcare innovation.
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 development within a highly specialized and regulated industry.
- Chance to contribute to medical technologies that directly improve healthcare outcomes worldwide.
- Competitive compensation and benefits package (based on location and experience).
