Product Safety Associate (m/f/d)

Da Vinci Engineering GmbH

60308 Frankfurt am Main - Deutschland

Ingenieur/in - Elektrotechnik Arbeit Teilzeit Abend ab 05.02.2026

Beschreibung

Nothing provides more motivation than success. Da Vinci Engineering is highly committed to ensuring the own employees' success. Become a part of us!

Product Safety Associate (m/f/d)

Stellen-ID: 21509
Standort: Frankfurt am Main

We are searching intelligent and innovative employees. If you are interested in working for a dynamic company with flat hierarchy, we look forward to receiving your application.

Your tasks:
- Reconciliation & Compliance:Regular reconciliation with distribution partners, affiliates, and external service providers; investigation and resolution of discrepancies, request and follow-up of RCA/CAPAs, escalation in case of repeated compliance breaches
- Safety Inbox & Triage:Identification, registration, prioritization, and duplicate check of incoming ICSRs (Medical Devices and Cosmetics); forwarding safety-relevant information to internal teams, partners, and service providers
- Outsourcing & Case Processing:Daily transfer of ICSRs to external providers, handling case-related queries; processing and quality control of clinical study SAEs, including MedDRA/IMDRF coding
- Distribution of Reports & Authority Requests:Forwarding of spontaneous adverse event reports and study reports to partners and PRRCs; support for regulatory submissions in compliance with national and international laws
- Invoice Verification:Detailed review of monthly invoices from external service providers to ensure task completion, accuracy, and timeliness
- SOP Management:Development, review, and implementation of SOPs according to applicable regulations (e.g., MPG, MDR, ISO standards)
- Audit Support:Support of auditees during preparation and throughout audits

Your profile:
- Scientific university degree OR Training as nurse, pharmaceutical technician, medical documentalist or similar
- Several years of product safety experience within the pharmaceutical or medical device industry
- Profound knowledge of medical device regulations in EU, Profound knowledge in the processing of ICSRs and in medical coding systems (MedDRA + IMDRF)
- Prior safety database experience
- Independent, analytical and conceptual work, Careful, reliable way of working
- Fluent in English in speech and writing

You can expect ...
- Experience in exciting and international projects
- Continuous salary development
- Da Vinci Corporate Benefits
- On-the-job training and language courses
- Appreciation, motivation and commitment

Kontaktdaten für Stellenanzeige
Frau Andrea Cindric

Da Vinci Engineering GmbH

Hauptstätter Straße 149

70178 Stuttgart

+49 711 72240 107

job@davinci.de

Ref-Nr.: 9152554

Aktualisiert: 05.02.2026

Quelle: Bundesagentur für Arbeit
weitere Infos Rechtliche Hinweise zur Nutzung
Ob die Stelle noch verfügbar ist und weitere Informationen findest du direkt auf der Website der Bundesagentur für Arbeit. Bitte beachte: OPROMA ist nicht der Anbieter dieser Stelle und kann keine Auskünfte geben.

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