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The Role: Biocompatibility Specialist
We are seeking a Biocompatibility & Technical Documentation Specialist as a freelancer for a company that is specialized in the development, production and distribution of medical devices for orthopaedics in the field of trauma.
Location: Berlin & Home-office 2-3 days/week (depending on the experience)
Responsibilities as Biocompatibility Specialist
*Technical control and implementation of biocompatibility assessments according to ISO10993 within the scope of material qualifications and medical device developments (for sterile and non-sterile products EU MDR class Im, Ir,IIa, IIb).
*Cooperation with other departments, such as production, development, Regulatory Affairs.
*Selection, planning, commissioning and monitoring of biocompatibility tests on external testing institutes according to ISO 10993 and other country-specific standards, regulatory requirements.
*Establishment and maintenance of contacts with testing institutes and external experts.
*Selection and commissioning of external service providers (e.g. reviewers, etc.).
Skills and Experience Required Biocompatibility Specialist
*Completed studies (diploma/MSc/doctorate) in the natural sciences (e.g. biology, biochemistry, pharmacology, medicine or similar).
*Technical understanding of toxicological in vitro and in vivo tests and evaluation of products and materials.
*Several years of practical experience in the medical device industry, ideally with Products of risk classes I-IIb.
*Experience in the performance/evaluation/ordering of analyses and tests according to ISO 10993
*Willingness to learn to deal with new, innovative technologies and materials
*Ability to adapt to new challenges in a rapidly changing and progressive environment framework conditions.
*Solution and goal-oriented analytical and conceptual skills with "Do -Attitute".
*Ability to take the initiative in tackling new tasks and to communicate these in a team and to be implemented.
*Fluent knowledge of German and English (oral and written).
How to apply
Apply here if you are interested in this opportunity please apply on the link below or if you would like a confidential discussion about your career opportunities please contact Lisa Gottheil of EPM Scientific.
Disclaimers if necessary: Must have the rights to Work in Germany
Biocompatibility Specialist (m/w/d)
- Location Berlin
- Job type Contract
- Salary ยฃ135 - ยฃ136 per hour
- Discipline Regulatory
- Reference CR/258391_1588779703
We are seeking a Biocompatibility & Technical Documentation Specialist as a freelancer for a company that is specialized in the development, production and distribution of medical devices for orthopaedics in the field of trauma.
Location: Berlin & Home-office 2-3 days/week (depending on the experience)
Responsibilities as Biocompatibility Specialist
*Technical control and implementation of biocompatibility assessments according to ISO10993 within the scope of material qualifications and medical device developments (for sterile and non-sterile products EU MDR class Im, Ir,IIa, IIb).
*Cooperation with other departments, such as production, development, Regulatory Affairs.
*Selection, planning, commissioning and monitoring of biocompatibility tests on external testing institutes according to ISO 10993 and other country-specific standards, regulatory requirements.
*Establishment and maintenance of contacts with testing institutes and external experts.
*Selection and commissioning of external service providers (e.g. reviewers, etc.).
Skills and Experience Required Biocompatibility Specialist
*Completed studies (diploma/MSc/doctorate) in the natural sciences (e.g. biology, biochemistry, pharmacology, medicine or similar).
*Technical understanding of toxicological in vitro and in vivo tests and evaluation of products and materials.
*Several years of practical experience in the medical device industry, ideally with Products of risk classes I-IIb.
*Experience in the performance/evaluation/ordering of analyses and tests according to ISO 10993
*Willingness to learn to deal with new, innovative technologies and materials
*Ability to adapt to new challenges in a rapidly changing and progressive environment framework conditions.
*Solution and goal-oriented analytical and conceptual skills with "Do -Attitute".
*Ability to take the initiative in tackling new tasks and to communicate these in a team and to be implemented.
*Fluent knowledge of German and English (oral and written).
How to apply
Apply here if you are interested in this opportunity please apply on the link below or if you would like a confidential discussion about your career opportunities please contact Lisa Gottheil of EPM Scientific.
Disclaimers if necessary: Must have the rights to Work in Germany