Deine Aufgaben

- Support compliant, efficient, and harmonized technology and product development, as well as lifecycle management activities with a focus on biological safety.
- Lead biological safety evaluations according to applicable standards and regulations, ensuring high-quality technical documentation.
- Serve as the technical contact person for peers and subject matter expert for biocompatibility-related topics.
- Build and maintain expertise in applicable regulations, standards, and requirements (e.g., ISO 10993 series, MDR 2017/745), translating them into streamlined internal processes and documentation.
- Lead third-party collaborations regarding biocompatibility testing, toxicological assessments, and biological evaluation activities.
- Collaborate with cross-functional teams across Regulatory Affairs, Quality, Risk Management, Manufacturing Engineering, and R&D.
- Communicate biological evaluation strategies, study outcomes, and risk assessments to relevant stakeholders (e.g., Regulatory Affairs, Quality, Risk Management, Manufacturing).
- Actively support continuous optimization of QMS processes, biological evaluation procedures, and testing strategies.
- Participate in internal and external audits and provide expert support for technical and regulatory questions.

Deine Qualifikationen

- Bachelor’s or Master’s in Medical Engineering, Toxicology, Natural Sciences, or equivalent. PhD in a relevant field is advantageous and will be preferred.
- 2-5 years of relevant experience in the medical device industry or a highly regulated scientific environment.
- Strong knowledge of ISO 10993 series, MDR 2017/745, risk management principles, and medical device development processes.
- Experience authoring and reviewing Biological Evaluation Plans (BEPs), Biological Evaluation Reports (BERs), and toxicological risk assessments.
- Experience with change management, non-conformities (NCs), and CAPAs.
- Strong analytical skills, solution-oriented mindset, and ability to influence cross-functional stakeholders.
- Ability to interpret technical drawings and mechanical designs
- Good verbal English skills; a clear communication style will be appreciated.

Deine Vorteile

- 30 days of annual leave
- Up to 60% mobile work possible + flexible work time model with overtime compensation
- Holiday and Christmas bonuses
- Corporate benefits discounts for employees
- Comprehensive company pension scheme and capital-forming benefits
- Company restaurant with live cooking and healthy food (subsidized)
- Employee Assistance Program of FamPLUS to support your health, mental and emotional well-being
- Subsidy for public transportation (Deutschlandticket), free parking spaces and bike or car leasing
- Various subsidized company sports groups and access to the inhouse company gym

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