R&D Specialist Biocompatibility (m/f/d)

OLYMPUS EUROPA SE & CO. KG; Hamburg; Hybrid; EUR 70,000 - 95,000; Full time

Benefits offered by this job

30 days leave

60% mobile work

Holiday bonus

Company pension

Free parking

Employee restaurant

Wellbeing support

Public transport subsidy

Company gym access

Job summary

Olympus Winter & Ibe GmbH seeks an R&D Specialist Biocompatibility to lead biological safety evaluations and author BEP/BER documentation. You will act as the SME for biocompatibility, translate ISO 10993 and MDR requirements into practical processes, and collaborate with Regulatory, Quality, Risk, and Manufacturing teams.

A strong regulatory background and clear communication are essential. You will participate in audits and help advance QMS procedures while supporting global product

Qualifications

• Must have formal education in a relevant scientific field with hands-on biocompatibility work.
• Experience in BEP/BER preparation and toxicological risk assessments is required.
• Strong regulatory awareness of ISO 10993 and MDR 2017/745 is essential.

Responsibilities

• Lead biocompatibility evaluations and maintain high-quality documentation.
• Act as a technical contact for biocompatibility topics across teams.
• Translate regulations into streamlined internal processes and records.
• Collaborate with Regulatory, Quality, Risk, Manufacturing, and R&D teams.
• Support audits and provide expert answers to regulatory questions.

Skills

Biocompatibility knowledge

Regulatory knowledge

Technical documentation

Cross-functional collaboration

English communication

Education

Bachelor’s or Master’s in Medical Engineering, Toxicology, Natural Sciences

Job description

R&D Specialist Biocompatibility (m/f/d)

Olympus Winter & Ibe GmbH (OWI)Chief Technology Officer

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

Further information:

Your future inclusive workplace awaits

We value the diversity of individuals, perspectives, and lifestyles, and prioritize inclusion and mutual respect. We are committed to fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish.