PROJEKTDETAILS
Biocompatibility Expert (m/w/d)
SOLCOM zählt zu den führenden Technologiedienstleistern in den Bereichen Softwareentwicklung, IT und Engineering. Seit mehr als 30 Jahren arbeiten wir als Partner global agierender Spitzenunternehmen aller Branchen und sind weltweit im Einsatz, wo Innovation entscheidet.
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.
- 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).
Zusätzliche Informationen:
Konnten wir Ihr Interesse wecken? Dann freuen wir uns auf die Zusendung Ihres aussagekräftigen Expertenprofils unter Angabe Ihrer Stundensatzvorstellung.
