Cytokinetics
Director, Regulatory Affairs, Europe(m/w/x)
VollzeitFreelancemit HomeofficeSenior
Zug
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Dein persönlicher KI-Karriere-Agent
NONovocure Inc
Senior Director, Clinical Regulatory Affairs(m/w/x)
Baar
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Global clinical regulatory strategy for Tumor Treating Fields therapy. 10-12 years regulatory affairs experience with Class III medical devices required. Flexible hybrid work, trust-based model.
Anforderungen
- Master’s degree in life sciences, biomedical engineering, or related field
- Advanced degree preferred
- 10–12 years regulatory affairs experience
- Experience across biotech, pharma, medical device environments
- Significant experience with Class III medical devices
- At least 5 years leadership experience
- Deep expertise with IDEs, PMAs, CE Mark submissions
- Global clinical regulatory strategy for high-risk devices
- Proven experience engaging directly with FDA and global authorities
- Experience with complex clinical and regulatory matters
- Strong understanding of clinical study design
- Strong understanding of statistical principles
- Strong understanding of regulatory requirements for oncology and high-risk devices
- Ability to develop regulatory strategies
- Strategies balancing scientific, clinical, regulatory, business objectives
- Strong leadership presence
- Exceptional communication skills
- Cross-functional influencing skills
- Experience supporting oncology-focused products or therapies
- Experience in pharma, biotech, medical device, or combination products
- Deep understanding of global regulatory environments
- Understanding of FDA, EU MDR, and Asian markets
- Familiarity with software as a medical device (SaMD)
- Familiarity with combination product environments
- Experience supporting product launch preparation
- Experience supporting commercialization activities
- Experience supporting advertising, promotion, and labeling strategies
- Familiarity with digital and social media regulatory review
- Experience operating in highly matrixed, global organizations
- Experience with connected regulatory strategy, clinical evidence, commercialization readiness
Aufgaben
- Develop and lead global clinical regulatory strategies
- Shape regulatory approaches for clinical evidence generation
- Partner with Clinical Affairs, Medical Affairs, R&D, Marketing, Legal, Quality, and Regulatory Operations
- Provide strategic regulatory guidance for clinical study design
- Lead interactions with global health authorities
- Prepare and lead teams through regulatory engagements
- Author and review high-quality regulatory documentation
- Interpret and apply complex global regulatory requirements
- Support global product launch readiness
- Contribute to internal governance discussions
- Lead, mentor, and develop a high-performing regulatory team
Berufserfahrung
- 10 - 12 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- IDEs
- PMAs
- CE Mark
Benefits
Flexibles Arbeiten
- Flexible hybrid working model
- Trust-based working model
- Hybrid work (3 days/week in office)
- Flexible schedule
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novocure Inc 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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NONovocure Inc
Senior Director, Clinical Regulatory Affairs(m/w/x)
Baar
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Global clinical regulatory strategy for Tumor Treating Fields therapy. 10-12 years regulatory affairs experience with Class III medical devices required. Flexible hybrid work, trust-based model.
Anforderungen
- Master’s degree in life sciences, biomedical engineering, or related field
- Advanced degree preferred
- 10–12 years regulatory affairs experience
- Experience across biotech, pharma, medical device environments
- Significant experience with Class III medical devices
- At least 5 years leadership experience
- Deep expertise with IDEs, PMAs, CE Mark submissions
- Global clinical regulatory strategy for high-risk devices
- Proven experience engaging directly with FDA and global authorities
- Experience with complex clinical and regulatory matters
- Strong understanding of clinical study design
- Strong understanding of statistical principles
- Strong understanding of regulatory requirements for oncology and high-risk devices
- Ability to develop regulatory strategies
- Strategies balancing scientific, clinical, regulatory, business objectives
- Strong leadership presence
- Exceptional communication skills
- Cross-functional influencing skills
- Experience supporting oncology-focused products or therapies
- Experience in pharma, biotech, medical device, or combination products
- Deep understanding of global regulatory environments
- Understanding of FDA, EU MDR, and Asian markets
- Familiarity with software as a medical device (SaMD)
- Familiarity with combination product environments
- Experience supporting product launch preparation
- Experience supporting commercialization activities
- Experience supporting advertising, promotion, and labeling strategies
- Familiarity with digital and social media regulatory review
- Experience operating in highly matrixed, global organizations
- Experience with connected regulatory strategy, clinical evidence, commercialization readiness
Aufgaben
- Develop and lead global clinical regulatory strategies
- Shape regulatory approaches for clinical evidence generation
- Partner with Clinical Affairs, Medical Affairs, R&D, Marketing, Legal, Quality, and Regulatory Operations
- Provide strategic regulatory guidance for clinical study design
- Lead interactions with global health authorities
- Prepare and lead teams through regulatory engagements
- Author and review high-quality regulatory documentation
- Interpret and apply complex global regulatory requirements
- Support global product launch readiness
- Contribute to internal governance discussions
- Lead, mentor, and develop a high-performing regulatory team
Berufserfahrung
- 10 - 12 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- IDEs
- PMAs
- CE Mark
Benefits
Flexibles Arbeiten
- Flexible hybrid working model
- Trust-based working model
- Hybrid work (3 days/week in office)
- Flexible schedule
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novocure Inc 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
Novocure Inc
Branche
Healthcare
Beschreibung
Das Unternehmen ist ein führender Anbieter von innovativen Therapien zur Behandlung von Krebs, insbesondere durch Tumor Treating Fields.
Noch nicht perfekt?
- Cytokinetics
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