Compliance

• Facilitate development of global regulatory strategies for medical devices and digital health solutions, including Artificial Intelligence (AI) exempt from the medical device classification, and connected technologies aligned with the Business Unit priority.
• Interface with International Regulatory Affairs Team to ensure global planning considerations are included in regulatory strategy development.
• Partner with Business Units to review product portfolios and provide regulatory input to strategic priorities.
• Oversee and facilitate communication of these strategies to product teams responsible for developing new products and solutions.
• Lead cross-functional teams with ownership and agility to ensure regulatory alignment with business objectives.
• Provide regulatory guidance, compliance risk assessment, and strategic input to digital product development and lifecycle management.
• Ensure that digital health products, services, and documentation comply with applicable global regulations (e.g., IEC 82340-1, IEC 81001-5-1, GDPR, HIPAA, EU AI Act, Cybersecurity regulations, and relevant consumer protection laws).
• Oversee and support regulatory submissions and compliance filings where applicable (e.g., AI risk classification documentation, cybersecurity certifications, and voluntary compliance frameworks).
• Respond to inquiries from regulatory authorities, auditors, or privacy/cybersecurity oversight bodies, while maintaining robust documentation for inspections or audits.
• Monitor evolving regulatory landscapes across multiple regions (U.S., EU, Japan, other APAC markets), staying current on emerging standards and frameworks for AI, digital health software, cybersecurity, and data privacy, and translate these changes into actionable strategies.
• Assess the impact of regulatory changes on Olympus’ digital health initiatives and collaborate with development, privacy, and business stakeholders to adapt strategies and maintain compliance.
• Support partnership initiatives to strengthen the Olympus Digital Health portfolio through well selected third-party collaborations with third-party providers, ensuring regulatory due diligence in vendor and technology selection.
• Represent Olympus in relevant digital health and regulatory industry associations, contributing Olympus’ perspective and staying connected to external developments.
• Develop and maintain SOPs, compliance frameworks, and internal guidance tailored to non-medical device digital health initiatives.
• Design and deliver regular training programs to ensure employees understand and follow best practices in compliance, regulatory considerations, and ethical use of digital health technologies.
• Review promotional materials and labelling generated by other non-Regulatory Affairs functions, in collaboration with regional Regulatory Affairs teams, to confirm they are accurate and compliant with applicable regulations.
• Act as an effective business partner, by driving quality mindset to reinforce the corporate brand and become a trusted, collaborative and preferred business partner across Olympus.
• Mentor, manage, and develop direct reports, fostering a culture of ownership, agility, and continuous learning.
• Provide training and guidance on regulatory policies, processes, and SOPs to build high-performing regulatory talent.

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