Biosafety & Biocompatibility Specialist | ISO 10993 Expert

LiNA Medical ApS; Poznań; Hybride; PLN 120 000 - 180 000; Plein temps

Avantages offerts par ce poste

Private medical care

Sports card

MyBenefit cafeteria system

Flexible working time

Home Office

English language classes

Fruits and snacks

Résumé du poste

LiNA Medical ApS seeks a biocompatibility specialist to lead biological safety assessments and device characterization in Poznań. You will ensure regulatory compliance for new and existing devices, prepare BEPs and BERs, and collaborate with R&D on technical documentation.

The role requires 2+ years in medical devices, strong knowledge of EU MDR and ISO 10993 standards, and excellent English communication for technical records and cross-functional teamwork.

Qualifications

• Higher education (M.Sc. or Ph.D.) in life sciences, biology, biotechnology, chemistry, or a related field.
• At least 2 years of experience in the medical device industry or in a relevant R&D/university setting.
• Knowledge of EU MDR (2017/745) and ISO 10993 standards.
• Understanding of risk-based approach per ISO 14971.
• Excellent written and spoken English for technical documentation.

Responsabilités

• Navigate ISO 10993-1:2025 and perform biological safety risk assessment and device characterization.
• Ensure biocompatibility and regulatory compliance for new and existing devices (BEPs/BERs).
• Conduct advanced toxicological and risk analyses (ISO 10993-17, -18, ISO 14971).
• Assess impact of material/process changes on the safety profile.
• Support R&D in creating/updating technical documentation on biocompatibility.

Connaissances

Analytical thinking

Team communication

Independent work

English proficiency

Formation

M.Sc. or Ph.D. in life sciences

Description du poste

LiNA Medical ApS seeks a biocompatibility specialist to lead biological safety assessments and device characterization in Poznań. You will ensure regulatory compliance for new and existing devices, prepare BEPs and BERs, and collaborate with R&D on technical documentation.

The role requires 2+ years in medical devices, strong knowledge of EU MDR and ISO 10993 standards, and excellent English communication for technical records and cross-functional teamwork.