ProClinical is advertising a vacancy for a Biocompatibility Specialist position to be based in Switzerland. This job is with the world's leading workforce management solutions company, which prides itself on its specialisation in multiple scientific and engineering sectors.
- 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.
- Writing Biocompatibility Protocols and Reports
- Providing input to gap assessment tools that may be needed for 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; reviewing the Biocompatibility (Toxicology) sections of the technical files for a number of products and product families, identifying and remediating any deficiencies, and generating biocompatibility risk assessments for each of the technical files,
- Functioning as Study Coordinator for outsourced studies
- Participating in the design and execution of pre-clinical 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 of 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 and implementing compliance strategies to support the sale of new and existing products, as well as implementing procedures in anticipation of regulatory activities.
- Working under minimal supervision, conducting research, and contributing to the origination and direction of experiments and new methodologies.
- Prioritising 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, with a specialisation in Cardiovascular a desirable bonus.
- A thorough understanding of MDR regulations, ISO 10993 standards.
- An understanding of Biochemistry, Analytical Chemistry, and Manufacturing, and how they is used within Medical Devices.
- Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
- 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 in 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 Sasha Brasero at + 44 203 078 9556 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.
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