Regulatory & Quality Assurance Manager in
vor 6 Monaten
Unser Kunde ist ein erfolgreiches **Familienunternehmen**, das **forschend tätig** ist und seine Produkte weltweit **marktführend** vertreibt.
Für die Niederlassung in **Wien** suchen wir eine*n Regulatory & Quality Assurance Manager*in. Dabei wenden wir uns an engagierte Persönlichkeiten mit ausgeprägtem wissenschaftlichem Interesse und Freude am gemeinsamen Gestalten und Umsetzen. Es erwartet Sie eine **verantwortungsvolle Aufgabe **mit guten beruflichen Perspektiven in einem **jungen Unternehmen, das Diversity hochschreibt**. Sie berichten an den Head of Medical Affairs.
**Ihre Aufgaben**:
**Regulatory Affairs**
- Regulatorisches Life-Cycle Management unter Berücksichtigung von nationalen Anforderungen
- Anpassung der Produktinformationen an nationale regulatorische Vorgaben sowie inhaltliche Prüfung und Freigabe
- Pflege von relevanten nationalen Datenbanken
- Fristgerechte, bidirektionale Koordination der Zulassungsangelegenheiten zwischen der Behörde und dem Stammhaus
- Information der betroffenen internen Stakeholder (Geschäftsführung, Marketing, Medical) über die Auswirkung von regulatorischen Prozessen auf deren Geschäftstätigkeiten
- Competitive Intelligence
**Quality Assurance**
- Erhaltung und laufende Verbesserung der Qualitätssicherungssysteme
- Sicherstellung der Einhaltung von SOPs nach GDP, GMP und allen relevanten regulatorischen und gesetzlichen Anforderungen
- Management der Erfassung, Bearbeitung und Beurteilung von Abweichungen
- Unterstützung bei internen Audits und Behördeninspektionen, Durchführung von Selbstinspektionen und externer Audits
**Ihre Qualifikationen**:
- Abgeschlossenes naturwissenschaftliches Studium
- Berufserfahrung im Bereich Regulatory Affairs und im Quality Management
- Sehr gute MS-Office Kenntnisse
- Proaktivität, selbständiges Arbeiten in einem cross-funktionellen Team
- Freude an selbstständiger Arbeit sowie an der Zusammenarbeit mit Kolleg*innen
**Das Angebot**:
- Langfristige Perspektive in einem erfolgreichen Familienunternehmen mit spannender Spezialisierung
- Intensive Einarbeitung und vielfältige Weiterbildungsangebote
- Herausragende nationale und internationale Schulungsveranstaltungen
- Proaktiver Teil eines dynamischen, familiären und offenen Teams zu sein, das Vielfalt als Bereicherung sieht
- Dotierung: Ab EUR 60.000 Jahresbruttogehalt zuzüglich variablem Anteil mit Bereitschaft zur Überzahlung entsprechend der Qualifikationen und Berufserfahrung
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