Heumann Pharma GmbH & Co. Generica KG
Manager Regulatory Affairs(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Nürnberg
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
ALAlcon
Regulatory Affairs Strategy Sr. Associate(m/w/x)
Erlangen
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Global medical device submissions and product approval support. 5+ years of hands-on regulatory affairs experience required. 6 weeks vacation, company car for private use.
Anforderungen
- Degree in Life Sciences, Biomedical Engineering, Pharmacy, or related field
- English and German fluency (written and verbal)
- 5+ years of experience with global medical device submissions
- Strong motivation to expand regulatory expertise
- Hands-on Regulatory Affairs experience
- Ready to take ownership of market submissions
- Cross-functional regulatory coordination experience
- Ability to work with technical documentation
- Ability to work with regulatory submissions
- Ability to work with compliance-related materials
- Strong attention to detail
- Solid communication skills
- Effective collaboration with cross-functional teams
- Professional interaction with regulatory agencies
- Strong organizational abilities
- Strong time-management abilities
- Support multiple tasks, submissions, and deadlines
- Work in a structured environment
- Commitment to quality
- Adherence to GxP
- Adherence to SOPs
- Accurate documentation practices
- Continuous learning through required trainings
Aufgaben
- Contribute to regulatory strategy development
- Support activities for product approvals
- Ensure alignment with global and local requirements
- Prepare regulatory submissions
- Coordinate regulatory submissions
- Collaborate with internal teams on submissions
- Work with manufacturing sites on submissions
- Liaise with regulatory agents on submissions
- Engage with health authorities on submissions
- Review promotional materials for compliance
- Review labeling for compliance
- Maintain technical documentation
- Maintain dossiers
- Support product lifecycle activities
- Assess regulatory impacts of changes
- Assist with regulatory pathways for modifications
- Ensure continuous compliance across the portfolio
- Facilitate cross-functional interactions
- Facilitate authority interactions
- Provide regulatory input
- Address country-specific queries
- Serve as a key communication point
- Maintain strict compliance with GxP
- Maintain compliance with quality systems
- Follow SOPs
- Keep thorough documentation
- Complete required training
- Contribute to audits
- Contribute to inspections
- Contribute to process improvements
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- EU MDR technical Documentation
- FDA 510(k)/PMAs
- Health Canada Class II & III
- ISO
Benefits
Sonstige Vorteile
- Product lifecycle management
- Supportive workplace
- Global leader
- Medical technology
Lockere Unternehmenskultur
- Team collaboration
Startup-Atmosphäre
- Dynamic workplace
Sinnstiftende Arbeit
- Life-changing advancements
Ergonomischer Arbeitsplatz
- Eye care
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Alcon 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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ALAlcon
Regulatory Affairs Strategy Sr. Associate(m/w/x)
Erlangen
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Global medical device submissions and product approval support. 5+ years of hands-on regulatory affairs experience required. 6 weeks vacation, company car for private use.
Anforderungen
- Degree in Life Sciences, Biomedical Engineering, Pharmacy, or related field
- English and German fluency (written and verbal)
- 5+ years of experience with global medical device submissions
- Strong motivation to expand regulatory expertise
- Hands-on Regulatory Affairs experience
- Ready to take ownership of market submissions
- Cross-functional regulatory coordination experience
- Ability to work with technical documentation
- Ability to work with regulatory submissions
- Ability to work with compliance-related materials
- Strong attention to detail
- Solid communication skills
- Effective collaboration with cross-functional teams
- Professional interaction with regulatory agencies
- Strong organizational abilities
- Strong time-management abilities
- Support multiple tasks, submissions, and deadlines
- Work in a structured environment
- Commitment to quality
- Adherence to GxP
- Adherence to SOPs
- Accurate documentation practices
- Continuous learning through required trainings
Aufgaben
- Contribute to regulatory strategy development
- Support activities for product approvals
- Ensure alignment with global and local requirements
- Prepare regulatory submissions
- Coordinate regulatory submissions
- Collaborate with internal teams on submissions
- Work with manufacturing sites on submissions
- Liaise with regulatory agents on submissions
- Engage with health authorities on submissions
- Review promotional materials for compliance
- Review labeling for compliance
- Maintain technical documentation
- Maintain dossiers
- Support product lifecycle activities
- Assess regulatory impacts of changes
- Assist with regulatory pathways for modifications
- Ensure continuous compliance across the portfolio
- Facilitate cross-functional interactions
- Facilitate authority interactions
- Provide regulatory input
- Address country-specific queries
- Serve as a key communication point
- Maintain strict compliance with GxP
- Maintain compliance with quality systems
- Follow SOPs
- Keep thorough documentation
- Complete required training
- Contribute to audits
- Contribute to inspections
- Contribute to process improvements
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- EU MDR technical Documentation
- FDA 510(k)/PMAs
- Health Canada Class II & III
- ISO
Benefits
Sonstige Vorteile
- Product lifecycle management
- Supportive workplace
- Global leader
- Medical technology
Lockere Unternehmenskultur
- Team collaboration
Startup-Atmosphäre
- Dynamic workplace
Sinnstiftende Arbeit
- Life-changing advancements
Ergonomischer Arbeitsplatz
- Eye care
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Alcon 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Alcon
Branche
Healthcare
Beschreibung
The company is a global leader in eye care, dedicated to helping people see brilliantly through innovative solutions.
Noch nicht perfekt?
- Heumann Pharma GmbH & Co. Generica KG
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