Biocompatibility Specialist

Hobson Prior are currently looking for a Biocompatibility Scientist to join a fantastic pharmaceutical organisation on a permanent basis located in Oberdorf. Our client is focused on improving people's access and affordability of treatments for creating healthier communities.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this role, you will be responsible for working alongside the site staff to trace and assess 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
• Understand and identify possible gaps for ISO 10993-1 and supporting ISO 10993 testing where needed.
• Write Biocompatibility Protocols and Reports.
• Provide input to gap assessment tools that may be needed for project assessments for each of the technical files.
• Function as Study Coordinator for outsourced studies.
• Contribute to 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.
• Work under a limited amount of supervision, conduct research and contribute to the origination and direction of experiments and new methodologies.
• Provide technical consultation on the implementation of experimental activities.
• Comply with Standard Operating Procedures to ensure compliance with FDA Good Laboratory Practices (21 CFR, Part 58).
• Collaborate with associates of diverse technical backgrounds (chemistry, physiology, materials science, engineering, supplier quality, manufacturing) to achieve desired project outcomes.

Key Skills:

• Robust project management skills
• Exceptional writing skills.
• Capability to prioritise tasks according to broad project objectives.

Requirements:

• Acquired experience within the MD industry.
• At least 2 years of experience in Biocompatibility.
• Practical experience with ISO 10993.
• Familiarity with MDR requirements is desirable but not essential.
• Medical device knowledge is crucial to the role.
• Comprehensive understanding of MDR regulations, ISO 10993 standards, and understanding of Biochemistry, Analytical Chemistry, Manufacturing and how it is used within Medical Devices.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.