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Olympus Corporation · 3 weeks ago

Senior Regulatory Affairs Specialist II, Digital Health

Greater Boston

Full-time

Onsite

Mid, Senior Level

$92K/yr - $129K/yr

7+ years exp

Olympus Corporation is a global medical technology company focused on advancing medical technologies and improving patient care. The Senior Regulatory Affairs Specialist II for Digital Health will support regulatory activities for the Olympus Digital Unit, ensuring compliance of digital health products with global regulatory requirements and collaborating with cross-functional teams throughout the product lifecycle.

ElectronicsIndustrialManufacturingMedical DeviceProduct Design

Responsibilities

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

Qualification

Regulatory AffairsDigital Health ComplianceRegulatory DocumentationGlobal Regulatory StrategyMedical Device RegulationsIEC StandardsChange ManagementEffective CommunicationOrganizational SkillsCross-Functional CollaborationWriting Skills

Required

BS or comparable in engineering or life sciences required

Minimum of 7 years prior regulatory affairs experience in the medical device industry, or a minimum of 5 years with master's degree

Previous experience working in a global environment; demonstrated sensitivity to cultural differences

Familiarity with digital health regulatory frameworks for medical devices and frameworks outside of traditional medical devices (IEC 62304, IEC 82304-1, IEC 81001-5-1, GDPR, HIPAA, EU AI Act)

Experience preparing or maintaining regulatory documentation and supporting submissions or audits

Understanding of global digital health regulatory landscapes and voluntary compliance schemes

Effective communicator with strong organizational and documentation skills

Ability to work independently while contributing to cross-functional project teams

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