Director Global Regulatory Affairs and Compliance - AI and Digital Health

Purpose of the Job

The Global Regulatory Affairs – AI and Digital Health lead and advances Global Regulatory Affairs’ capability, strategy, and governance for AI, digital health, software, connected solutions, and data-driven technologies across Sonova. Embedded within the Global Regulatory Affairs organization and broader QARA structure, the role shapes the regulatory frameworks, governance approach, and decision principles needed to enable compliant digital innovation in an environment where regulatory expectations, digital services, and business models are still evolving.

As the primary Global RA partner to the Chief Digital Officer organization and digital and AI initiative teams, the role provides strategic regulatory leadership for enterprise digital priorities from within Global Regulatory Affairs, while maintaining clear accountability boundaries with Legal, Data Privacy, Cybersecurity, Quality, R&D, Digital, Clinical, and Commercial functions. The role strengthens organizational capability through fit-for-purpose frameworks, practical regulatory guidance, and consistent cross-functional alignment, without assuming functional ownership of adjacent domains.

The role is a key enabler of Sonova’s sustainable digital transformation and long-term success by shaping fit-for-purpose regulatory approaches for digital services and related technologies in a fast-evolving and still-maturing digital and AI regulatory environment.

Tasks & Responsibilities

• Shape Global Regulatory Affairs’ regulatory approach for AI, digital health, software, connected solutions, and data-driven technologies by setting frameworks, governance models, and decision principles for these domains
• Serve as the primary Global RA counterpart to the Chief Digital Officer organization and digital and AI initiative teams, anchoring the Regulatory Affairs position on digital services and related technologies
• Drive Sonova’s cross-functional and cross-regional regulatory alignment on AI and digital topics, while product Regulatory Affairs strategy remains owned by the respective Global Regulatory Affairs managers
• Shape Sonova’s regulatory approach to evolving global requirements and standards for AI and digital technologies, translating ambiguity into clear business direction and governance principles
• Ensure Sonova is appropriately engaged and represented in key policies, industry, and external forums relevant to digital and AI topics, strengthen regulatory awareness, positioning, and preparedness
• Establish scalable regulatory frameworks, practical guidance, capability-building approaches, and the Regulatory Affairs AI policy that strengthen Global RA and Regional RA readiness for digital and AI topics
• Define clear regulatory interfaces and accountability boundaries with Legal, Data Privacy, Cybersecurity, Quality, R&D, Digital, Clinical, and Commercial functions to support aligned, risk-based decision-making
• Represent Regulatory Affairs in governance forums, authority interactions, audits, inspections, and other external engagements relevant to AI and digital topics, as appropriate

Requirements

• Bachelor’s degree in life sciences, engineering, biomedical sciences, software, computer science, regulatory affairs, or a related field
• 10+ years of progressive Regulatory Affairs experience in regulated industries, with significant experience in software, digital health, AI-enabled technologies, connected solutions, or related innovation areas.
• Strong experience developing regulatory strategies and supporting product or technology development from concept through lifecycle management.
• Proven success shaping regulatory frameworks and leading cross-functional regulatory direction for emerging digital or AI-enabled technologies in a global matrix environment
• Strong risk-based decision-making, regulatory interpretation, and ability to translate ambiguity into practical regulatory positions
• Ability to influence without direct authority, align complex stakeholder groups, and communicate effectively at senior leadership level
• Strong matrix leadership and stakeholder influence across technical, business, and governance functions.
• Ability to shape regulatory direction in areas where regulatory approaches and governance models are still evolving, translate ambiguity into practical risk-based decisions, and drive alignment without direct line authority
• Strong knowledge of regulatory requirements and governance considerations for AI, software, digital health, connected solutions, data-driven technologies, and related regulated products and services.
• Solid understanding of risk management, lifecycle management, cybersecurity interfaces, and data/privacy considerations.
• Ability to shape regulatory direction for AI and digital topics within a broader Global RA strategy. Ability to understand AI, software, data, connectivity, cybersecurity interfaces, and digital health concepts sufficiently to guide regulatory strategy and lifecycle decisions.
• Ability to build knowledge, connect expertise, mentor professionals, establish playbooks, and develop sustainable organizational competence
• Very good English skills, written and spoken
• Proficient in Microsoft Office and collaboration tools
• Ability to operate effectively in a global matrix organization, support multiple strategic initiatives in parallel, and collaborate across time zones