Sartorius Stedim Biotech GmbH
Regulatory Affairs Professional Medical Devices(m/w/x)
Vollzeitmit HomeofficeBerufserfahren
Göttingen
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SASartorius Stedim Biotech GmbH
Quality and Regulatory Compliance Auditor(m/w/x)
Göttingen
Vollzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
Managing quality audit programs and regulatory affairs for a global life science company. Supervisory experience in regulated environments and medical device ISO certifications required. 35-hour work week, 30 vacation days.
Anforderungen
- Master's degree in scientific discipline or comparable
- Supervisory experience in regulated environment
- Medical device and ISO certification qualifications
- Effective collaboration in cross-functional teams
- Experience with notified bodies and auditing
- Qualification as medical device manufacturing auditor
- Knowledge in regulations and authority interfacing
- Expertise in major regulatory submissions
- Strong interpersonal and personnel dealing skills
- Advanced organizational and prioritization skills
- Business fluent German and English skills
- Willingness to travel approximately 20%
Aufgaben
- Manage the business unit quality audit program
- Provide specialist input for regulatory affairs processes
- File applications and manage interactions with authorities
- Write and review governing quality system procedures
- Support continuous process improvement efforts
- Maintain risk assessments for compliance-related elements
- Monitor staff training records and personnel files
- Track deviations and master schedules
- Review protocols and reports for internal and external projects
- Coordinate responses to observations and incidents
- Update databases to ensure accuracy and compliance
- Prepare and edit documentation for regulatory submissions
- Develop operating guidelines and shared work practices
- Create optimal strategies for assigned projects
- Implement regulatory strategies for upcoming regulations
- Offer guidance to multidisciplinary teams on compliance
- Train and mentor team members and consultants
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- ISO related certifications
Benefits
Mehr Urlaubstage
- Vacation bonus
- 30 vacation days
Boni & Prämien
- Holiday bonus
Betriebliche Altersvorsorge
- Pension benefits
Mentoring & Coaching
- Mentoring
- Talent Talks
- Coaching for managers
- Buddy program
- Coaching communities
Karriere- und Weiterentwicklung
- Leadership programs
- Business women network
Weiterbildungsangebote
- Internal seminar offerings
- Welcome Workshops
Flexibles Arbeiten
- Remote options
- Flextime
- Flexible work schedules
Workation & Sabbatical
- Sabbaticals
Modernes Büro
- Open office spaces
- Terraces
Gratis oder Vergünstigte Mahlzeiten
- Company restaurant
- Vegetarian and vegan options
- Bistro with ice cream
Gesundheits- & Fitnessangebote
- Fitness studio
Kinderbetreuung
- Daycare center
Sonstige Vorteile
- Comprehensive onboarding
- Virtual onboarding platform
Lockere Unternehmenskultur
- Mutual support and teamspirit
- International collaboration
Startup-Atmosphäre
- Agile working communities
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
Quality and Regulatory Compliance Auditor(m/w/x)
Göttingen
Vollzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
Managing quality audit programs and regulatory affairs for a global life science company. Supervisory experience in regulated environments and medical device ISO certifications required. 35-hour work week, 30 vacation days.
Anforderungen
- Master's degree in scientific discipline or comparable
- Supervisory experience in regulated environment
- Medical device and ISO certification qualifications
- Effective collaboration in cross-functional teams
- Experience with notified bodies and auditing
- Qualification as medical device manufacturing auditor
- Knowledge in regulations and authority interfacing
- Expertise in major regulatory submissions
- Strong interpersonal and personnel dealing skills
- Advanced organizational and prioritization skills
- Business fluent German and English skills
- Willingness to travel approximately 20%
Aufgaben
- Manage the business unit quality audit program
- Provide specialist input for regulatory affairs processes
- File applications and manage interactions with authorities
- Write and review governing quality system procedures
- Support continuous process improvement efforts
- Maintain risk assessments for compliance-related elements
- Monitor staff training records and personnel files
- Track deviations and master schedules
- Review protocols and reports for internal and external projects
- Coordinate responses to observations and incidents
- Update databases to ensure accuracy and compliance
- Prepare and edit documentation for regulatory submissions
- Develop operating guidelines and shared work practices
- Create optimal strategies for assigned projects
- Implement regulatory strategies for upcoming regulations
- Offer guidance to multidisciplinary teams on compliance
- Train and mentor team members and consultants
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- ISO related certifications
Benefits
Mehr Urlaubstage
- Vacation bonus
- 30 vacation days
Boni & Prämien
- Holiday bonus
Betriebliche Altersvorsorge
- Pension benefits
Mentoring & Coaching
- Mentoring
- Talent Talks
- Coaching for managers
- Buddy program
- Coaching communities
Karriere- und Weiterentwicklung
- Leadership programs
- Business women network
Weiterbildungsangebote
- Internal seminar offerings
- Welcome Workshops
Flexibles Arbeiten
- Remote options
- Flextime
- Flexible work schedules
Workation & Sabbatical
- Sabbaticals
Modernes Büro
- Open office spaces
- Terraces
Gratis oder Vergünstigte Mahlzeiten
- Company restaurant
- Vegetarian and vegan options
- Bistro with ice cream
Gesundheits- & Fitnessangebote
- Fitness studio
Kinderbetreuung
- Daycare center
Sonstige Vorteile
- Comprehensive onboarding
- Virtual onboarding platform
Lockere Unternehmenskultur
- Mutual support and teamspirit
- International collaboration
Startup-Atmosphäre
- Agile working communities
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
Pharmaceuticals
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
Regulatory Affairs Professional Medical Devices(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenGöttingen - Sartorius Corporate Administration GmbH
Inhouse Consultant BPM - Quality Management(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenGöttingen - Sartorius Corporate Administration GmbH
Temporary Job Change: Test & Application Manager(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenGöttingen - Sartorius Stedim Biotech GmbH
Business Process Expert – Service Process Development(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenGöttingen - Sartorius Stedim Biotech GmbH
Temperature Logistics Expert(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenGöttingen