Expert Biological Safety / Toxicology for Medical Devices

• full-time or 32 hrs/week - permanent contract -

Ref. No. 2020-17/HP

Role and Responsibilities

• You are responsible for the biological evaluation of medical devices in the framework of the Medical Device Regulation (MDR), ISO 10993-series and other relevant regulatory guidelines/requirements
• You are responsible for the development of biological evaluation strategies
• You are responsible for the performance of toxicological risk assessments for medical devices, based on the used raw materials, on extractable and leachable chemicals or on biocompatibility studies
• You are responsible for the preparation of scientific expert statements
• You will act as study monitor and client representative for biocompatibility studies placed at contract laboratories
• You will assure the high quality within projects (i.e. reports, expert statements, correspondence, quotations)
• You are responsible for customer support in validation of sterilization processes and of packaging materials
• You are responsible for communication and close co-operation with our customers and relevant authorities

Profile and Qualifications

• You have an university degree preferably in toxicology, biology or a related field
• You have a board certification as toxicologist (ERT, DABT or equivalent)
• You have more than five years professional experience in regulatory toxicology and biological safety
• You have detailed knowledge of risk assessment approaches and of in vivo and in vitro methods for safety / toxicology assessment
• You have excellent language skills in English (spoken and written); additional language skills would be an asset
• You have excellent communication, presentation and organizational skills in a multinational environment
• You have a proactive personality with the ability to work self-motivated
• You have a high personal responsibility with decision-making ability
• You have a service oriented personality and attitude
• You are a quick learner, able to react to new challenges

Benefits

• You will work in a dynamic field in a collegial and appreciative team
• A well-structured induction plan will make your start easier and your further education will be supported by our knoell Academy
• On average each employee has 3 days of further education per year
• We support you in balancing your work and private life and offer you 30 days of vacation, a childcare allowance and family-friendly flexible working time models
• In addition to your fixed salary, we grant your commitment with performance-related bonuses
• We provide you with a lucrative employee participation program
• You will receive a canteen allowance and we will offer you coffee, tea and water for free
• To strengthen our team spirit, team events are held in addition to the annual employee meeting
• We also ensure your financial stability after retirement - through the offer of a company pension plan

Location

Mannheim, Leverkusen, Berlin (Germany), also other locations in Europe

knoell Germany GmbH

Human Resources
Konrad-Zuse-Ring 25
D-68163 Mannheim
Do you have questions? Please contact Mrs Marion Lohnert, phone
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