Define and evolve the global QMS strategy for digital health technologies, including SaMD, AI/ML‑enabled systems, cloud‑based platforms, and automated workflows.
Interpret and operationalize global regulatory and standards requirements (e.g., FDA, EU MDR/IVDR, ISO 13485, IEC 62304, ISO 62366, ISO 14971, GxP data integrity) as they apply to digital and informatics solutions.
Partner with R&D, IT, Product Management, Regulatory Affairs, PMO, and Technical Quality to ensure quality by design is embedded throughout the digital product lifecycle.
Establish governance models, procedural frameworks, and decision pathways that enable agile and scalable digital innovation while maintaining regulatory compliance.
Lead risk‑based approaches for software lifecycle management, cybersecurity, data governance, AI/ML change control, and algorithm performance monitoring.
Serve as a thought leader and internal consultant on emerging regulatory expectations related to AI/ML, real‑world data, automation, and digital transformation.
Perform other work-related duties as assigned.

Bachelors and/or technical degree in Life Sciences, Pharmacy, Engineering, Computer Science, Biomedical Engineering or a related technical discipline.
8-10 years of progressively responsible experience within a regulated Quality Management System environment, with significant exposure to software, digital health, or informatics solutions.
Demonstrated ability to lead QMS strategy development and influence senior stakeholders across complex, matrixed organizations.
Strong understanding of global regulatory frameworks applicable to digital health, SaMD, AI/ML, and automated systems.
Proven experience applying risk management, design controls, software lifecycle processes, and post market surveillance to digital products.
Ability to translate regulatory and quality requirements into practical, scalable processes that support innovation.
Bias toward action, with a track record of driving execution aligned to organizational strategy.
Excellent written and verbal communication skills, including the ability to represent quality positions to executive leadership.
Strong collaboration skills and the ability to operate effectively across technical, regulatory, and business functions.
Willingness and ability to travel approximately 10–15%.

Digital Informatics QMS Strategy Lead

Key skills