Compliance

• Participate in product teams developing new digital health technologies and connected software systems.
• As needed provide input to define global regulatory strategy requirements.
• Participate in teams for sustaining products to provide input on global regulatory requirements.
• Support regulatory submissions, filings, and responses to regulatory or auditor inquiries as directed.
• Interface with International Regulatory Affairs Team and drive preparation of dossiers for registration on for other international markets such as Japan, Middle East and Africa, Australia and Latin America.
• Assist in ensuring that Olympus digital health solutions comply with applicable global regulations and standards (e.g., IEC 82304-1, IEC 81001-5-1, GDPR, HIPAA, EU AI Act, cybersecurity and consumer protection laws).
• Monitor evolving regulatory frameworks related to digital health, AI, and data privacy, summarizing key updates and communicating their impact to relevant stakeholders.
• Assist with maintenance of regulatory files and databases to ensure prompt and accurate access to company regulatory information.
• Provide dashboard updates concerning current pending and future approvals for Regulatory Affairs management.
• As needed assist in the development and maintenance of regulatory standard operating procedures (SOPs), work instructions, and templates related to digital health compliance.
• Assist with training activities to promote awareness of regulatory requirements and best practices among Digital Unit teams.

Senior Regulatory Affairs Specialist II, Digital Health

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