Olympus Winter & Ibe GmbH (OWI)
R&D Specialist Reprocessing Execution (m/w/x)
Vollzeitmit HomeofficeBerufserfahren
Hamburg
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OLOlympus Europa SE & Co. KG
Clinical Evaluation Manager (m/w/x)
Vollzeitmit HomeofficeBerufserfahren
AI/ML
Nejo KI-Zusammenfassung
Authoring Clinical Evaluation Reports (CERs) and coordinating vendor-prepared documents for medical devices. Master's or PhD in Health Sciences with 3+ years of MedTech CER authoring required. 30 days holidays, flexible working hours, and remote work up to 60%.
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Anforderungen
- Master's or PhD in Health Sciences, Life Sciences, Medicine, or related field
- Minimum 3 years authoring Clinical Evaluation Reports (CERs)
- Minimum 3 years in Medical Device (MedTech) industry
- Strong expertise in literature research, evidence appraisal, data analysis, medical writing
- In-depth knowledge of EU MDR, EU MDD, MEDDEV 2.7/1 Rev. 4, MDCG, ISO 14971
- Ability to independently manage complex projects and deliver results
- Strong analytical and problem-solving skills
- Excellent verbal and written communication skills
- Ability to build trust, drive accountability, achieve results collaboratively
- Strong commitment to continuous learning and professional development
- Highly organized, self-motivated, efficient, proactive, team-oriented mindset
- Experience with AI/LLM technologies, understanding limitations and risks
Aufgaben
- Create, maintain, and manage CER and SSCP documents per regulatory requirements
- Coordinate, review, and oversee vendor-prepared CERs and SSCPs for quality and compliance
- Conduct systematic literature reviews and critically evaluate clinical evidence for medical devices, products, and procedures using databases like PubMed, Embase, and Cochrane
- Analyze and interpret scientific literature to support clinical evaluations, regulatory submissions, and post-market activities
- Collaborate with Product Management, R&D, Risk Management, Quality Assurance, and Regulatory Affairs to provide clinical evidence and support product lifecycle and development
- Plan, initiate, and support Post-Market Clinical Follow-Up (PMCF) activities with internal stakeholders
- Manage annual forecasting and budget planning for regional CER activities and documentation, including supplier costs
- Prepare, support, and participate in internal and external audits and inspections
- Mentor, train, and supervise working students, interns, and junior CER Managers, fostering expertise in literature research, clinical evidence assessment, and medical writing
- Contribute to continuous improvement initiatives and provide team support
Berufserfahrung
3 Jahre
Ausbildung
Doktor / Ph.D.
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
EU MDREU MDDMEDDEV 2.7/1 Rev. 4MDCG guidelinesISO 14971AI/LLM technologies
Benefits
Flexibles Arbeiten
- Flexible working hours
- Remote work possible (up to 60%)
Mehr Urlaubstage
- 30 days of holidays
Modernes Büro
- Modern office
Startup-Atmosphäre
- Inspiring working environment
Gratis oder Vergünstigte Mahlzeiten
- Subsidized employee restaurant with live cooking
Öffi Tickets
- 100% subsidized public transport ticket
Parkplatz & Pendelvorteile
- Free parking space
Gesundheits- & Fitnessangebote
- Company sport groups
- Inhouse company gym
- Company medical officer
- Vaccination offers
Mentale Gesundheitsförderung
- Employee Assistance Program
Betriebliche Altersvorsorge
- Comprehensive company pension scheme
Kinderbetreuung
- Childcare through partner
Firmenfahrrad
- Bike leasing
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Olympus Europa SE & Co. KG erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei Olympus Europa SE & Co. KGÜber das Unternehmen
OL
HealthcareHamburg
The company is a global medical technology company that partners with healthcare professionals to provide solutions for early detection and treatment.
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