W.O.M. World of Medicine GmbH
Medical Affairs Manager Medical Devices(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Berlin
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W.W.O.M. World of Medicine GmbH
Medical Affairs Manager(m/w/x)
Berlin
VollzeitVor OrtBerufserfahren
AI/ML
Nejo KI-Zusammenfassung
Managing medical device conformity, PMS/PSUR documentation, and PMCF plans for engineered healthcare components. Medical device industry experience and expert medical writing skills required. Focus on precision engineered components for healthcare and advanced manufacturing.
Anforderungen
- Degree in life/natural science or equivalent
- Experience in medical device industry
- Understanding of Medical Affairs processes
- Expert knowledge in medical writing
- Creation of Clinical Evaluation Plans
- Strong attention to detail
- Knowledge of regulatory requirements
- Knowledge of Minimally Invasive Surgery
- Knowledge in Clinical investigation
- Fluent English and German skills
- Open and competent stakeholder attitude
- IT affinity and MS Office proficiency
- Familiarity with AI tools
- Willingness to travel on demand
- Valid passport for international travel
- Mobility for standard office work
Aufgaben
- Maintain product compliance with regulatory guidelines
- Ensure medical device conformity with safety requirements
- Prepare and update PMS and PSUR documentation
- Manage PMCF plans and reports
- Develop clinical evaluation plans and reports
- Maintain audit-ready documentation at all times
- Support risk and change management processes
- Handle nonconformance and corrective actions
- Conduct scientific literature and vigilance searches
- Evaluate data according to MDR and MEDDEV standards
- Plan studies for CE-registrations and PMCF
- Collaborate with R&D and product management teams
- Coordinate with external service providers
- Conduct annual PMCF surveys in hospitals
- Attend conferences to track clinical innovations
- Follow quality and occupational safety regulations
- Implement environmental management instructions
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Abgeschlossene Berufsausbildung
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- PRISMA
- PICO
- MDR
- MDCG
- MEDDEV
- ISO 13485
- ISO 14971
- QSR (FDA)
- ISO 14155
- ISO 14115
- MS Office
- AI tools
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
Lead Regulatory Affairs Specialist(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - W.O.M. World of Medicine GmbH
Senior Regulatory Affairs Specialist Medical Devices(m/w/x)
Vollzeitnur vor OrtSeniorBerlin
W.W.O.M. World of Medicine GmbH
Medical Affairs Manager(m/w/x)
Berlin
VollzeitVor OrtBerufserfahren
AI/ML
Nejo KI-Zusammenfassung
Managing medical device conformity, PMS/PSUR documentation, and PMCF plans for engineered healthcare components. Medical device industry experience and expert medical writing skills required. Focus on precision engineered components for healthcare and advanced manufacturing.
Anforderungen
- Degree in life/natural science or equivalent
- Experience in medical device industry
- Understanding of Medical Affairs processes
- Expert knowledge in medical writing
- Creation of Clinical Evaluation Plans
- Strong attention to detail
- Knowledge of regulatory requirements
- Knowledge of Minimally Invasive Surgery
- Knowledge in Clinical investigation
- Fluent English and German skills
- Open and competent stakeholder attitude
- IT affinity and MS Office proficiency
- Familiarity with AI tools
- Willingness to travel on demand
- Valid passport for international travel
- Mobility for standard office work
Aufgaben
- Maintain product compliance with regulatory guidelines
- Ensure medical device conformity with safety requirements
- Prepare and update PMS and PSUR documentation
- Manage PMCF plans and reports
- Develop clinical evaluation plans and reports
- Maintain audit-ready documentation at all times
- Support risk and change management processes
- Handle nonconformance and corrective actions
- Conduct scientific literature and vigilance searches
- Evaluate data according to MDR and MEDDEV standards
- Plan studies for CE-registrations and PMCF
- Collaborate with R&D and product management teams
- Coordinate with external service providers
- Conduct annual PMCF surveys in hospitals
- Attend conferences to track clinical innovations
- Follow quality and occupational safety regulations
- Implement environmental management instructions
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Abgeschlossene Berufsausbildung
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- PRISMA
- PICO
- MDR
- MDCG
- MEDDEV
- ISO 13485
- ISO 14971
- QSR (FDA)
- ISO 14155
- ISO 14115
- MS Office
- AI tools
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 Medical Devices(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
Lead Regulatory Affairs Specialist(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - W.O.M. World of Medicine GmbH
Senior Regulatory Affairs Specialist Medical Devices(m/w/x)
Vollzeitnur vor OrtSeniorBerlin