Senior Manager m/w/d Regulatory Affairs

Franz & Wach Personalservice GmbHPenzberg

Stellenbeschreibung:

Regulatory Dossiers & Submissions: Compile and manage complex submission dossiers for IVD product registrations, with a primary focus on navigating peak submission periods in China.
Strategy & Compliance: Interpret global healthcare regulatory frameworks, anticipate potential obstacles, and implement strategic risk-mitigation plans.
Cross-Functional Collaboration: Partner effectively with key stakeholders across R&D, QC, and international teams, maintaining close alignment with Chinese Regulatory Affairs counterparts.
Leadership & Influence: Mentor junior team members, guide decision-making across interfaces, and promote an inclusive, high-performing team environment.
Problem Solving & Innovation: Independently troubleshoot complex regulatory issues, drive process improvements, and leverage digital tools to maintain data compliance.
Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience (Completed training as a technician or laboratory technician; or equivalent qualification for the tasks
At least 5 years experience, 5-7 Years preferred, in Regulatory, R&D, Quality, Operations and/or Clinical Some experience in Healthcare regulatory affairs. Advanced degree is considered an advantage.
Can manage more complexity work and/or global projects, or equivalent experience.
English fluent in spoken and written
Working mostly independently, confident to approach interfaces (e.g. R&D, QC, and the Chinese Regulatory Affairs colleagues)
Experience from Regulatory Affairs in China would be very desirable

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