Regulatory Affairs Program Manager, Digital Health

Job Description

Working

Location:

MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK; PENNSYLVANIA, CENTER VALLEY

Workplace Flexibility:

Field

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 responsible for coordinating and managing regulatory activities across the Digital Unit (DU). The Digital Unit is a global, high-growth area focused on how digital technologies can help transform current and future products.

This individual will play a key role in establishing and assessing regulatory strategies and requirements for digital health products and solutions, ensuring compliance with global medical device regulations. As part of a high-growth, innovative team, this position oversees collaboration between internal Olympus Regulatory Affairs Teams and external vendors as needed and will work closely with the DU's development teams to drive digital transformation in the medical technology space.

This role involves researching, recommending, and implementing regulatory best practices, contributing to both the strategic and operational functions of the Digital Unit.

• Develop and implement regulatory strategies for digital health solutions, including Artificial Intelligence (AI) exempt from the medical device classification, and connected technologies.
• 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).
• 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.
• Oversee and support regulatory submissions and compliance filings where applicable (e.g., AI risk classification documentation, cybersecurity certifications, and voluntary compliance frameworks).
• Support responses to inquiries from regulatory authorities, auditors, or privacy/cybersecurity oversight bodies, and ensure appropriate documentation is maintained 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.
• Serve as a liaison between Olympus RA teams, digital product development teams, quality assurance, privacy, cybersecurity, and business units, fostering alignment across functions.
• Represent Olympus in relevant digital health and regulatory industry associations, contributing Olympus’ perspective and staying connected to external developments.
• Develop, implement, and maintain standard operating procedures (SOPs), compliance frameworks, and internal regulatory guidance specific 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.

Required:

• BS or comparable required.
• Minimum of 10 years’ experience in Regulatory Affairs, ideally within the medical device or digital health industries.
• Minimum of 3 years focused on software-driven health technologies.
• Experience with regulatory compliance for digital health software not classified…