CK QLS are recruiting for a Biocompatibility Specialist to join a company leading medical device company at their site based in Oberdorf. The position is offered on a contract basis for 12 months, with the possibility of extension.
Biocompatibility Specialist Role:
- Locate and review existing Technical File/Design Dossier/Design History File documentation and the support Product, Biocompatibility, Manufacturing Processes, Sterilization, Packaging and/or Cleaning Validation information for MDR transformation.
- Understand and identify possible gaps for ISO 10993-1 and supporting ISO 10993 testing where needed.
- Develop Toxicology/Biocompatibility Risk Assessment Strategies and write the Toxicological Risk Assessment report in collaboration with other team members.
- 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.
- Participate 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,).
- Experience in the Medical Device Industry.
- Good experience in Biocompatibility.
- Good familiarity with ISO 10993-1 and 10993-18.
- Familiar with MDR Requirements.
- Project management experience.
- Excellent writing skills.
- Experience within Cardiovascular would be an advantage.
For more information or to apply for this Biocompatibility Specialist position, please contact CK Group, quoting job ref 48813.
Please send all of your correspondence in English.
It is essential that applicants hold entitlement to work in Switzerland.