Senior Manager, Regulatory Affairs, Digital Health

Working

Location:

MASSACHUSETTS, WESTBOROUGH

Workplace Flexibility:
Hybrid

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling.

Every day, we live by our philosophy,True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our

Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus:

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.

• 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…