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

Olympus Corporation; Hamburg; Híbrido; EUR 65 000 - 95 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

30 Tage Jahresurlaub

Mobiles Arbeiten bis zu 60%

Urlaubs- und Weihnachtsgeld

Betriebliche Altersvorsorge

Unternehmensrestaurant

Employee Assistance Program

Deutschlandticket-Zuschuss

Kostenlose Parkplätze

Fahrrad-/Autoleasing

Zugang zu Fitnessstudio

Resumo da oferta

Olympus Corporation sucht eine Fachkraft im Bereich Biokompatibilität, um biologische Bewertungen zu leiten und regulatorische Anforderungen in Produktentwicklung und Lifecycle-Management zu integrieren. Sie arbeiten eng mit Regulatory Affairs, Quality, Risk Management, Manufacturing Engineering und R&D zusammen.

Zu den Aufgaben gehören die Erstellung/Überprüfung von BEP und BER, sowie Kommunikation von Bewertungsstrategien und Ergebnissen an Stakeholder.

Qualificações

• Fundierte Kenntnisse in Biokompatibilität, ISO 10993 und MDR 2017/745.
• Erfahrung mit BEP/BER und toxikologischen Bewertungen.
• Starke analytische Fähigkeiten und lösungsorientierte Herangehensweise.

Responsabilidades

• Leitung biologischer Sicherheitsbewertungen gemäß Standards und Regularien.
• Technischer Ansprechpartner für Biokompatibilitäts-Themen und -Dokumentation.
• Aufbau/Weiterentwicklung von Regulations-, Risikomanagement- und QMS-Prozessen.

Conhecimentos

Biocompatibility

Regulatory knowledge

Cross-functional collaboration

Analytical skills

Formação académica

Bachelor/Master in Medical Engineering

Descrição da oferta de emprego

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