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Olympus Corporation · 1 day ago

Senior Manager, Regulatory Affairs, Digital Health

Greater Boston

Full-time

Hybrid

Senior Level, Lead/Staff

$117K/yr - $164K/yr

10+ years exp

Olympus Corporation is a global medical technology company focused on advancing medical technologies and improving patient care. They are seeking a Senior Manager for Regulatory Affairs in Digital Health to lead regulatory activities across their Digital Unit, ensuring compliance with global regulations and supporting the development of innovative digital health solutions.

ElectronicsIndustrialManufacturingMedical DeviceProduct Design

Responsibilities

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

Qualification

Regulatory AffairsDigital Health SolutionsSoftware as a Medical DeviceGlobal Regulatory StrategiesAI ComplianceCybersecurity RegulationsData PrivacyProject ManagementAgile MethodologiesTraining DevelopmentLeadership SkillsInterpersonal SkillsCommunication SkillsProblem-Solving Skills

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

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