Post Market Surveillance Specialist

vor 4 Wochen

Berlin, Deutschland Novanta Vollzeit

Novanta is one global team with over 26 offices located in The Americas, Europe and Asia-Pacific. Looking for a great place to work? You have found it with a culture that embraces teamwork, collaboration and empowerment. Come explore Novanta.

WOM ist ein Wegbereiter und ein weltweit führender Hersteller in der Medizintechnik. Für unser Entwicklungsteam Insufflatoren in Berlin suchen wir Verstärkung. Wenn Sie gern eigenverantwortlich arbeiten, neue Wege in der mínimal-invasiven Medizin mit uns beschreiten und sich konsequent weiterentwickeln wollen, sollten wir uns näher kennenlernen.

Das bieten wir Ihnen
- Vielseitige Aufgaben in einer spannenden Arbeitsumgebung
- Internationale Teamarbeit
- Wertschätzung und Respekt
- Systematische Fortbildung
- Raum für Innovationen
- Karriereperspektiven in einem expandierenden Unternehmen

WOM Berlin sucht einen

Post Market Surveillance Specialist (m/w/d)

Bildung und Ausbildung

abgeschlossenes naturwissenschaftliches, medizinisches oder technisches Studium oder vergleichbare Qualifikation

Technisches Anforderungsprofil
- Selbstständige englische Sprachverwendung (GER-C1)*
- Fähigkeit, komplexe Arbeitsabläufe zu koordinieren

Persönliches Anforderungsprofil
- Qualitätsbewusst, vertrauenswürdig und zuverlässig
- Bereitschaft zu Reisen zu allen Standorten und Geschäftskontakten
- Strukturierte und systematische Arbeitsweise

Bereich der Aktivitäten

Abteilung Aufgaben

Funktionen:

- als klinischer und medizinischer Experte das Unternehmen vertreten
- Bereitstellung von Fachwissen für die Überwachung nach dem Inverkehrbringen

Post Market Surveillance
- Prozessverantwortlicher für Post Market Surveillance SOP
- Überblick über alle PMS-Dokumente und den jeweiligen Revisionsstand in den Geschäftsbereichen
- Sammlung, Auswertung und Aktualisierung der von anderen Abteilungen erhaltenen Daten, z.B. Beschwerdemanagement
- Erfassung, Auswertung und Aufbereitung von Kundendaten für PMS
- Aufbereitung von Daten zur Weitergabe an Kunden für deren eigenes PMS
- Rechtzeitige Aktualisierung der PMS-Dokumente
- Integration der Anforderungen des MDSAP und des ROW PMS

Wachsamkeit
- Prozessverantwortlicher für Vigilance SOP
- Projektleiter und Koordinator des Rückrufteams
- Interne und externe Kontaktperson für alle Rückrufangelegenheiten
- Rechtzeitige Rückrufmeldung an und Kommunikation mit Behörden
- Regelmäßige Berichterstattung über den Fortschritt des Rückrufs an den Leiter zur Vorlage bei der Geschäftsleitung
- Gründliche Rückrufdokumentation
- Definierte endgültige Dokumentation

Allgemeine Aufgaben
- Initiierung und aktive Beteiligung an Maßnahmen für Synchro-Prozesse
- Aktive Beteiligung am Innovationsprozess
- Strenge Einhaltung von Qualitäts-, Arbeitsschutz
- und Umweltvorschriften
- ) Gemeinsamer europäischer Referenzrahmen für Sprachen (CEFR)

___________________________________

WOM is a pioneer and a leading global manufacturer in medical technology. For our development team Insufflators in Berlin we are looking for reinforcement. If you like to work independently, break new ground in mínimally invasive medicine with us and want to develop consistently, we should get to know each other better.

What we offer you
- Versatile tasks in an exciting working environment
- International teamwork
- Appreciation and respect
- Systematic training
- Room for innovation
- Career prospects in an expanding company

WOM Berlin is looking for a

Post Market Surveillance Specialist (M/F/d)

Education and training

completed scientific, medical or technical degree program or comparable qualification

Technical requirements profile
- Independent English language usage (GER-C1)*
- Ability to coordinate complex workflows

Personal requirements profile
- Quality-conscious, trustworthy and reliably
- Willingness to travel to all locations and business contacts
- Team player
- Communication skills
- Structured and systematic working approach

Sphere of activities

Tasks department

Functions:

- Serve as the clinical and medical expert representing the company
- Provide expertise to post market surveillance activities

Post Market Surveillance
- Process owner of Post Market Surveillance SOP
- Overview of all PMS documents and the respective revision status across business units
- Collection, evaluation and updating of data received from other departments e.g. complaint management
- Collection, evaluation and preparation of customer data for PMS
- Preparation of data for forwarding to customers for their own PMS
- Timely Update of PMS documents
- Integrating MDSAP and ROW PMS requirements

Vigilance
- Process owner of Vigilance SOP
- Project leader and coordinator of the recall team
- Internal and external contact person for all recall matters
- On time recall reporting to and communication with authorities
- Regular reporting on the progress of the recall to leader for submission to management
- Thorough recall documentation
- Defined final docum

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