Projektdetails

Currently we are looking for a 'Biocompatibility Expert (m/f/d)' for supporting the planning and execution of the biocompatibility process (considering
applicable norms and standards) in terms of sustaining of existing products.

Auslastung: 100 Stunden/Monat
Einsatzort: Remote

Your responsibilities include:
+ Gap Assessments of the existing documentation according to MDR/ 510(k) requirements
+ Update/ Prepare technical documentation according to MDR/ 510(k) requirements e.g., BTPL, Reprocessing Protocols, LABS, TREP, Inputs for BEP & BRA, BIORV (These tasks are limited to the preparatory work.)

+ Communication with laboratories (content must be agreed in advance).

+ Minimum Bachelor's or master's degree in biomedical engineering, Biology, Toxicology, Life Sciences, Materials Science, or a related field. Candidates with PhD should be given preference.
+ Proven experience in biocompatibility activities for medical devices, the ISO 10993 series, especially biological evaluation and risk assessment processes.
+ Practical experience preparing or updating biocompatibility documentation for MDR and FDA 510(k) submissions.

Experience with technical documentation such as:

Biological Test Plans
Biological Evaluation Plan
Biological Risk Assessment/Biological Evaluation Report

Biological Evaluation Report supporting documentation

Toxicological Risk Evaluation documentation

+ Understanding of EU MDR requirements related to biocompatibility.

+ Experience working with external testing laboratories and coordinating test-related activities.

+ Strong technical writing and documentation skills.

+ Professional English language skills (written and spoken).