W.O.M. World of Medicine GmbH
Medical Affairs Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Berlin
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W.W.O.M. World of Medicine GmbH
Medical Affairs Manager Medical Devices(m/w/x)
Berlin
VollzeitVor OrtBerufserfahren
AI/ML
Nejo KI-Zusammenfassung
Clinical evaluation and safety reporting for minimally invasive surgery and robotics components at medical technology manufacturer. Expert medical writing and database management for MDR-compliant documentation required. Post-market surveillance focus, 30 days vacation.
Anforderungen
- University degree in life/natural science or equivalent
- Medical device industry professional experience
- Basic understanding of Medical Affairs processes
- Expert medical writing and database management
- Creation of Clinical Evaluation Plans and Reports
- Strong attention to detail and documentation
- Knowledge of regulatory requirements (MDR, ISO)
- Knowledge of Minimally Invasive Surgery application
- Expertise in Medical Device clinical investigation
- Fluent English and German language skills
- Open and competent stakeholder management attitude
- IT affinity and MS Office proficiency
- Familiarity with AI tools
- Willingness to travel by public transportation
- Valid passport for international travel
Aufgaben
- Ensure product compliance with regulations and guidelines
- Implement procedures demonstrating clinical performance and safety
- Maintain audit-ready documentation required by MDR and MEDDEV
- Update Post Market Surveillance plans and reports
- Manage Periodic Safety Update Reports for products
- Develop Post-Market Clinical Follow-up plans and reports
- Create Clinical Evaluation plans and reports
- Manage documentation for new and legacy products
- Oversee Medical Affairs processes including Risk and Change Management
- Manage Nonconformance and Corrective and Preventive Actions
- Conduct scientific literature and vigilance searches
- Evaluate searches according to MDR and MEDDEV standards
- Plan studies for CE-registrations and PMCF
- Coordinate with Regulatory Affairs and Product Management
- Collaborate with R&D and external service providers
- Conduct annual PMCF surveys in hospital environments
- Participate in professional conferences to gain clinical insights
- Comply with quality and occupational safety regulations
- Follow environmental management and safety specialist instructions
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Abgeschlossene Berufsausbildung
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- MS Office
- AI tools
- PRISMA
- PICO
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens W.O.M. World of Medicine GmbH 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.
Noch nicht perfekt?
- W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist Medical Devices(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - Novanta Group Europe GmbH
Product Manager Medical Devices(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin - W.O.M. World of Medicine GmbH
Senior Regulatory Affairs Specialist Medical Devices(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist(m/w/x)
Vollzeitnur vor OrtSeniorBerlin
W.W.O.M. World of Medicine GmbH
Medical Affairs Manager Medical Devices(m/w/x)
Berlin
VollzeitVor OrtBerufserfahren
AI/ML
Nejo KI-Zusammenfassung
Clinical evaluation and safety reporting for minimally invasive surgery and robotics components at medical technology manufacturer. Expert medical writing and database management for MDR-compliant documentation required. Post-market surveillance focus, 30 days vacation.
Anforderungen
- University degree in life/natural science or equivalent
- Medical device industry professional experience
- Basic understanding of Medical Affairs processes
- Expert medical writing and database management
- Creation of Clinical Evaluation Plans and Reports
- Strong attention to detail and documentation
- Knowledge of regulatory requirements (MDR, ISO)
- Knowledge of Minimally Invasive Surgery application
- Expertise in Medical Device clinical investigation
- Fluent English and German language skills
- Open and competent stakeholder management attitude
- IT affinity and MS Office proficiency
- Familiarity with AI tools
- Willingness to travel by public transportation
- Valid passport for international travel
Aufgaben
- Ensure product compliance with regulations and guidelines
- Implement procedures demonstrating clinical performance and safety
- Maintain audit-ready documentation required by MDR and MEDDEV
- Update Post Market Surveillance plans and reports
- Manage Periodic Safety Update Reports for products
- Develop Post-Market Clinical Follow-up plans and reports
- Create Clinical Evaluation plans and reports
- Manage documentation for new and legacy products
- Oversee Medical Affairs processes including Risk and Change Management
- Manage Nonconformance and Corrective and Preventive Actions
- Conduct scientific literature and vigilance searches
- Evaluate searches according to MDR and MEDDEV standards
- Plan studies for CE-registrations and PMCF
- Coordinate with Regulatory Affairs and Product Management
- Collaborate with R&D and external service providers
- Conduct annual PMCF surveys in hospital environments
- Participate in professional conferences to gain clinical insights
- Comply with quality and occupational safety regulations
- Follow environmental management and safety specialist instructions
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Abgeschlossene Berufsausbildung
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- MS Office
- AI tools
- PRISMA
- PICO
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens W.O.M. World of Medicine GmbH 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.
Über das Unternehmen
W.O.M. World of Medicine GmbH
Branche
Healthcare
Beschreibung
The company creates engineered components and sub-systems for healthcare and advanced manufacturing, enhancing productivity and precision.
Noch nicht perfekt?
- W.O.M. World of Medicine GmbH
Medical Affairs Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin - W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist Medical Devices(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - Novanta Group Europe GmbH
Product Manager Medical Devices(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin - W.O.M. World of Medicine GmbH
Senior Regulatory Affairs Specialist Medical Devices(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist(m/w/x)
Vollzeitnur vor OrtSeniorBerlin