An international staffing and recruiting company is currently recruiting a Biocompatibility Specialist to join their office in Germany. This organisation is one of the largest workforce management solutions companies in the world who specialise in multiple scientific and engineering sectors. This is an exciting opportunity to work with a firm dedicated to innovative and dynamic approaches to the changing workforce landscape.
- Working with site staff to locate and review existing Technical File/Design Dossier/ Design History File documentation and the supporting Product, Biocompatibility, Manufacturing Processes, Sterilisation, Packaging and/or Cleaning Validation information for MDR transformation.
- Understanding and identifying possible gaps for ISO 10993-1 and supporting ISO 10993 testing where needed.
- Familiar with writing Biocompatibility Protocols and Reports.
- Providing input to gap assessment tools that may be needed for the project.
- Developing Toxicology/Biocompatibility Risk Assessment Strategies and writing the Toxicological Risk Assessment report in collaboration with other team members in support of a variety of projects of diverse scope.
- Participating in project teams as required. Toxicologist will review the Biocompatibility (Toxicology) sections of the technical files for a number of products and product families, to identify and remediate any deficiencies, and generate biocompatibility risk assessments for each of the technical files.
- Functioning as the Study Coordinator for outsourced studies.
- Participating in the design and execution of preclinical efficacy and safety studies used to assess the biocompatibility and safety of medical devices, drugs, and combination products such as sutures, meshes and hemostats in accordance with regulatory requirements (ISO, ICH, GLP).
- Maintaining current knowledge in existing regulations, requirements and standards, including but not limited to global regulatory requirements (ISO, ICH, FDA, etc) and compliance requirements (GLP, departmental SOP's, company policies, etc).
- Interpreting regulations, implementing compliance strategies to support the sale of new and existing products, as well as implement procedures in anticipation of regulatory activities.
- Working under minimal supervision, conduct research and contribute to the origination and direction of experiments and new methodologies.
- Prioritise tasks according to broad project goals.
- Providing technical consultation on the implementation of experimental activities.
- Complying with Standard Operating Procedures to ensure compliance with FDA Good Laboratory Practices (21 CFR, Part 58).
- Collaborating with associates of diverse technical backgrounds (chemistry, physiology, materials science, engineering, supplier quality, manufacturing) to achieve desired project outcomes.
Skills and Requirements:
- Medical device knowledge is a must, Cardiovascular.
- Thorough understanding of MDR regulations, ISO 10993 standards.
- Understanding of Biochemistry, Analytical Chemistry, Manufacturing and how it is used within Medical Devices.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Chidozie Orji at 0207 440 0671 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.