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Olympus Corporation · 15 hours ago

Regulatory Affairs Program Manager, Digital Health

Greater Boston

Full-time

Hybrid

Senior Level, Lead/Staff

$104K/yr - $146K/yr

10+ years exp

Olympus Corporation is a global medical technology company focused on enhancing healthcare through innovative solutions. The Regulatory Affairs Program Manager for Digital Health will coordinate and manage regulatory activities for digital health products, ensuring compliance with global medical device regulations while collaborating with various teams to drive innovation in the medical technology space.

ElectronicsIndustrialManufacturingMedical DeviceProduct Design

Responsibilities

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

Qualification

Regulatory AffairsDigital Health ComplianceAI Regulatory StrategyCybersecurity RegulationsSoftware-driven Health TechnologiesData Protection KnowledgeProject ManagementStakeholder ManagementCommunicationProblem-solving Skills

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 as medical devices, including AI-enabled consumer health platforms, and connected technologies

Expertise in digital health regulatory affairs, with knowledge of relevant frameworks and guidance outside 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

Demonstrated knowledge 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 to ensure both compliance and agility in product development Mindset & Behaviours are upheld

Demonstrated ability to influence colleagues without direct managerial responsibility and build strong collaborative relationships within the organization

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

Passion to challenge the status quo and find new strategic directions – embraces change

Comfortable pushing back on multiple parties at the same time

Excellent writing and verbal skills

Travel on occasion, but not more than 10 %

Preferred

MS preferred

Strong understanding or hands-on experience in software development and cloud technologies; experience with enterprise software and modern software engineering practices is desirable

Experience with 510(k), De Novo submissions, CE marking, and international regulatory pathways for Software as a Medical Device highly desirable