Your Responsibilities
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.
Your qualification
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.
Your benefits
- 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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R&D Specialist Biocompatibility (m/f/d) in Hamburg Arbeitgeber: Olympus Corporation
Olympus ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in der Region Berlin, Magdeburg, Dessau und Neubrandenburg nicht nur ein inspirierendes Arbeitsumfeld bietet, sondern auch zahlreiche Vorteile wie 30 Urlaubstage, ein Employee Assistance Program und eine umfassende betriebliche Altersvorsorge. Die Unternehmenskultur fördert die persönliche und berufliche Weiterentwicklung, während die enge Zusammenarbeit mit Experten im Gesundheitswesen sicherstellt, dass Sie an innovativen Lösungen für medizinische Herausforderungen mitwirken können.
