Sartorius Stedim Biotech GmbH
Quality and Regulatory Compliance Auditor(m/w/x)
Vollzeitmit HomeofficeBerufserfahren
Göttingen
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SASartorius Stedim Biotech GmbH
Regulatory Affairs Professional Medical Devices(m/w/x)
Göttingen
Vollzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
Preparing clinical and post-market surveillance documents for IVDs and related technical documentation in the EU at a global life science company translating scientific discoveries. Master's degree in natural sciences or related field, with first Regulatory Affairs experience for IVDs essential. 30 vacation days, remote options.
Anforderungen
- Master’s degree in natural sciences, medical technology, biotechnology, or comparable field
- First experience in Regulatory Affairs for Medical Devices and/or In Vitro Diagnostics
- Experience in scientific writing, especially Post-Market Surveillance and clinical documents
- Knowledge in interpretation of regulations and cooperation with regulatory authorities
- Excellent organizational skills and ability to set priorities
- Excellent analytical skills and knowledge of scientific principles
- Assertiveness, resilience, good sense for counterpart, clear communication, and people management skills
- Fluent German and English skills, both spoken and written
Aufgaben
- Prepare clinical and performance data documents
- Create post-market surveillance documents for medical devices and IVDs
- Support the Regulatory Affairs Specialist with technical documentation in the EU
- Develop schedules and ensure compliance
- Monitor market developments and conduct research
- Evaluate research findings
- Perform risk assessments and initiate corrective actions for incidents
- Analyze new regulatory requirements and implement necessary activities
- Advise internal stakeholders on regulatory changes and standards
- Communicate with authorities and submit regulatory documents
- Assess the regulatory impact of product changes
- Develop and implement new processes to meet regulatory requirements
- Write procedures and work instructions
- Monitor compliance with regulatory procedures and workflows
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Benefits
Attraktive Vergütung
- Attractive compensation
Boni & Prämien
- Vacation and holiday bonuses
Betriebliche Altersvorsorge
- Pension benefits
Mehr Urlaubstage
- 30 vacation days
Flexibles Arbeiten
- Remote options
- Flextime
- Flexible work schedules
Workation & Sabbatical
- Sabbaticals
Modernes Büro
- Open office spaces
Gratis oder Vergünstigte Mahlzeiten
- Company restaurant with vegetarian and vegan options
Gesundheits- & Fitnessangebote
- Fitness studio
Kinderbetreuung
- Daycare center
Sonstige Vorteile
- Comprehensive onboarding
- Mutual support
Lockere Unternehmenskultur
- Team spirit
- International collaboration
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Sartorius Stedim Biotech 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.
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SASartorius Stedim Biotech GmbH
Regulatory Affairs Professional Medical Devices(m/w/x)
Göttingen
Vollzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
Preparing clinical and post-market surveillance documents for IVDs and related technical documentation in the EU at a global life science company translating scientific discoveries. Master's degree in natural sciences or related field, with first Regulatory Affairs experience for IVDs essential. 30 vacation days, remote options.
Anforderungen
- Master’s degree in natural sciences, medical technology, biotechnology, or comparable field
- First experience in Regulatory Affairs for Medical Devices and/or In Vitro Diagnostics
- Experience in scientific writing, especially Post-Market Surveillance and clinical documents
- Knowledge in interpretation of regulations and cooperation with regulatory authorities
- Excellent organizational skills and ability to set priorities
- Excellent analytical skills and knowledge of scientific principles
- Assertiveness, resilience, good sense for counterpart, clear communication, and people management skills
- Fluent German and English skills, both spoken and written
Aufgaben
- Prepare clinical and performance data documents
- Create post-market surveillance documents for medical devices and IVDs
- Support the Regulatory Affairs Specialist with technical documentation in the EU
- Develop schedules and ensure compliance
- Monitor market developments and conduct research
- Evaluate research findings
- Perform risk assessments and initiate corrective actions for incidents
- Analyze new regulatory requirements and implement necessary activities
- Advise internal stakeholders on regulatory changes and standards
- Communicate with authorities and submit regulatory documents
- Assess the regulatory impact of product changes
- Develop and implement new processes to meet regulatory requirements
- Write procedures and work instructions
- Monitor compliance with regulatory procedures and workflows
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Benefits
Attraktive Vergütung
- Attractive compensation
Boni & Prämien
- Vacation and holiday bonuses
Betriebliche Altersvorsorge
- Pension benefits
Mehr Urlaubstage
- 30 vacation days
Flexibles Arbeiten
- Remote options
- Flextime
- Flexible work schedules
Workation & Sabbatical
- Sabbaticals
Modernes Büro
- Open office spaces
Gratis oder Vergünstigte Mahlzeiten
- Company restaurant with vegetarian and vegan options
Gesundheits- & Fitnessangebote
- Fitness studio
Kinderbetreuung
- Daycare center
Sonstige Vorteile
- Comprehensive onboarding
- Mutual support
Lockere Unternehmenskultur
- Team spirit
- International collaboration
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Sartorius Stedim Biotech 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
Sartorius Stedim Biotech GmbH
Branche
Healthcare
Beschreibung
The company is a growing global life science company that helps translate scientific discoveries into real-world medicine.
Noch nicht perfekt?
- Sartorius Stedim Biotech GmbH
Quality and Regulatory Compliance Auditor(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenGöttingen - Sartorius Stedim Biotech GmbH
Product Manager Bioprocessing Software & Automation(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenGöttingen - Sartorius Stedim Biotech GmbH
Technical Communication Professional(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenGöttingen - Sartorius Corporate Administration GmbH
Inhouse Consultant BPM - Quality Management(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenGöttingen - Sartorius Stedim Biotech GmbH
Temperature Logistics Expert(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenGöttingen