Senior Manager, Regulatory Affairs, Digital Health

Job Description

This role is a digital-native leader responsible for shaping, coordinating, and managing regulatory activities across the Digital Unit (DU). The DU is a high-growth, global innovation hub, focused on how digital technologies and data-driven solutions can transform healthcare beyond traditional medical devices.

This leadership role leads an OSTA Core Regulatory Affairs Team and provides world-class regulatory strategies for digital health solutions, ensuring compliance with applicable global requirements while proactively navigating evolving regulatory landscapes. Acting with agility and strategic foresight, this role helps establish best practices and scalable processes to support Olympus’ digital transformation journey. 

This position supports the Global Senior Manager to plan and direct the OSTA Core Regulatory Affairs Team activities including but not limited to analysis of requirements and resource allocation to support new product development teams’ preparation and submission of regulatory documentation for product registration/licensing in selected markets. This role involves researching, recommending, and implementing regulatory best practices balancing strategic vision with operational execution as well as interaction and liaising with R&D and Business leaders for successful market introduction.

Job Duties

• Strategic Leadership and Portfolio Alignment:
  
  • 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. 
• Regulatory Guidance and Compliance Execution:
  
  • 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.
• External Engagement and Partnerships:
  
  • 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.
• Operational Excellence & Culture of Compliance:
  
  • 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.
• Leadership & Team Development:
  
  • 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.

Job Qualifications

Required:

• BS or comparable in engineering or life sciences required.
• Minimum of 10 years of Regulatory Affairs experience, ideally within the medical device or digital health industries.
• Minimum of 3 years focused on software-driven health technologies.
• Demonstrated management experience in a matrix organization.
• Proven experience designing, writing, and submitting regulatory filings (e.g., 510(k), CE Mark, etc.) and securing approvals in spaces aligned to the digital health product portfolio, specifically Software as a Medical Device.
• Demonstrated leadership in managing the global submission process for regulatory approvals across multiple markets.
• Experience supporting end-to-end product lifecycle management for digital health solutions in major markets, such as North America, EMEA, Japan, and China.
• Experience defining global regulatory strategies for digital health solutions in collaboration with functions across the business.
• Deep experience in regulatory compliance for digital health software not classified as medical devices, including AI-enabled consumer health platforms, and connected technologies.
• Strong knowledge of frameworks and standards outside traditional medical device pathways (e.g., IEC 82304-1, IEC 81001-5-1, GDPR, HIPAA, EU AI Act, Cybersecurity regulations, and relevant consumer protection laws).
• Strong track record of leading regulatory strategy for digital health solutions in cross-functional environments, including product development, data science, cybersecurity, and business leadership teams.
• Strong understanding of data protection, cybersecurity, and digital trust frameworks, including NIST Cybersecurity Framework, ISO/IEC 27001, and emerging AI ethics guidelines.
• Experience with digital product compliance documentation (e.g., data protection impact assessments, AI risk classification reports, cybersecurity certifications) and voluntary compliance schemes.
• Experience working in a global matrix environment and managing interactions with regulators, privacy authorities, and standards organizations.
• Skilled in working within regulated software development environments (Agile, DevOps) to ensure compliance requirements are integrated into sprint planning and delivery.
• Strong ability to align digital, business, and R&D leadership on global regulatory expectations, balancing compliance with innovation.
• Strong problem-solving skills and an agile, ownership-driven mindset to ensure compliance supports speed and innovation in product development.
• Leadership and interpersonal skills to develop and manage good working relationships within Regulatory Affairs and with other internal departments (R&D, Manufacturing, Supply Chain, Quality etc).
• Excellent communication and stakeholder management skills to facilitate collaboration across teams and external partners.
• Strong project management skills with the ability to coordinate cross-functional teams and manage multiple regulatory projects/initiatives.
• A digital-native, change-embracing mindset, with a passion to challenge the status quo and explore new strategic approaches.
• Confidence in pushing back on multiple stakeholders while maintaining productive collaboration.
• Excellent writing and verbal skills.
• On occasion, but not more than 10%.

Preferred:

• MS in engineering or life sciences preferred.
• RAC accreditation or post-graduate degree preferred.
• Strong understanding or hands-on experience in software development and cloud technologies; experience with enterprise software and modern software engineering practices is desirable.