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Das könntest du laut kununu User:innen als Regulatory Affairs Manager:in in Österreich verdienen
Ø 63.400 €
Bruttodurchschnittsgehalt Vollzeit
44.200 €94.600 €
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Was die Firma über den Job sagt
Regulatory Affairs Specialist
At Roche, we are dedicated to advancing science and ensuring global access to healthcare. We are seeking a professional to manage regulatory approvals, maintain product licenses throughout their lifecycle, and ensure compliance across defined markets.
Responsibilities
- Oversee the development of complex submission and registration dossiers.
- Manage external stakeholder relationships and support audit preparation and execution.
- Lead organizational adaptation to evolving regulatory environments and solve critical health authority issues.
- Develop innovative regulatory strategies to accelerate worldwide approvals.
- Partner with cross-functional stakeholders to provide solutions and influence project directions.
- Drive innovation and troubleshoot issues to ensure compliance and business value.
Requirements
- Bachelor’s degree in Life Science, Data Science, or related field (Master’s degree preferred).
- 5-10 years of experience in the field of IVDs or Medical devices with significant Regulatory Affairs expertise.
- Fluent in English.
- Demonstrated ability to manage complex work and global projects.
- Expertise in China, EU, and US regulations is considered a significant advantage.
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