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:
- Work with site staff to locate and review existing Technical File/Design Dossier/ Design History File documentation and the supporting Product, Biocompatibility, Manufacturing Processes, Sterilization, Packaging and/or CleaningValidation information for MDR transformation
- Understand and identify possible gaps for ISO 10993-1 and supporting ISO 10993 testing where needed.
- Familiar with writing Biocompatibility Protocols and Reports
- Provide input to gap assessment tools that may be needed for project
- 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,).
- Participate in the development of strategies to support the sale of new and existing products, as well as implement procedures in anticipation of regulatory activities.
- Collaborate with associates of diverse technical backgrounds (chemistry, physiology, materials science, engineering, supplier quality, manufacturing) to achieve desired project outcomes.
- Thorough understanding of MDR regulations, ISO 10993 standards,and understanding of Biochemistry, Analytical Chemistry, Manufacturing and how it is used within Medical Devices
- Experience in the Medical Device Industry.
- Good experience in Biocompatibility.
- Good familiarity with ISO 10993-1
- Familiar with MDR Requirements.
- Project management experience.
- Excellent writing skills.
Apply: For more information or to apply for this Biocompatibility Specialist position, please contact Dennis on +41 (0) 800 106106 or email firstname.lastname@example.org, quoting job ref 49795. Please send all of your correspondence in English. It is essential that applicants hold entitlement to work in Switzerland.