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 permanent contract.
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 Cleaning Validation 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.
Please quote reference 50431. Please send all of your correspondence in English.
It is essential that applicants hold entitlement to work in Switzerland.
You MUST be eligible to work in Switzerland. Learn more
- Agency: CK Group
- Contact: Jocelyn Blackham
- Phone: 01438 723 500
- Reference: 50431
Website: CK Group
- Posted: 21st April 2021
- Expires: 19th May 2021