Roche

Compliance

• Provide strategic direction and representation of Regulatory Affairs in international and interdisciplinary teams.
• Manage neurology, cardiology and core reagents product registrations in the United States, Europe and China and support worldwide registrations.
• Give regulatory guidance on strategic and tactical topics to stakeholders and cross-functional project teams.
• Prepare and submit premarket submissions to FDA or Notified Bodies, serving as the primary interface.
• Interact with regulatory agency personnel to expedite approval/clearance of pending registrations and answer questions.
• Support product care activities and update technical documentation of the product portfolio.
• Collaborate closely with colleagues in Germany, Switzerland, the US and global Regulatory Affairs teams, especially in China and Japan.

Regulatory Affairs Manager

• Develop and implement the AI readiness, data insights, and digitalization strategy and roadmap for the Q&R Compliance organization
• Define and champion business cases and use cases for digital tools and AI to optimize processes and reduce manual effort
• Drive development and maintenance of AI-powered solutions (e.g., agents) and standardized human- and machine-readable technical content
• Continuous optimization of content creation and knowledge management tools to meet the needs of more than 40,000 Roche Diagnostics employees
• Collaborate with Training and Audit Chapters and stakeholders across Roche Diagnostics, Group IT and People & Culture to implement use cases
• Identify skill gaps and lead upskilling and training initiatives across the Q&R Compliance organization
• Serve as a member of the Q&R Compliance Leadership Team and act as a catalyst for change
• Stay current with emerging technologies in AI, data analytics, and digital tools and drive innovation

Regulatory Affairs Manager

Data & AI Solutions Lead – Quality & Regulatory