Usability and Regulatory Affairs Specialist

At Sentec, we are passionate about advancing patient care through innovative medical technology. We are seeking a Usability & Regulatory Affairs Specialist to play a critical role in ensuring our products are safe, effective, and compliant with global regulations.

In this cross-functional role, you will lead human factors and usability engineering activities while also supporting regulatory submissions and strategy. You will work closely with engineering, clinical, and quality teams to identify and mitigate use-related risks—ultimately helping bring high-impact medical technologies to market.

What You’ll Do

Human Factors & Usability

• Plan and execute formative and summative usability studies, including protocol development, participant selection, test moderation, data analysis, and reporting in line with applicable regulatory expectations
• Develop and maintain usability engineering documentation, including use specifications, task analyses, use-related risk analyses, and the usability engineering file, in accordance with IEC 62366 and FDA guidance
• Collaborate with cross-functional teams and external partners to identify use-related risks early, and drive design improvements based on study findings

Regulatory Affairs

• Support the compilation of submission dossiers for new registrations and changes to existing approvals in close collaboration with internal and external stakeholders
• Support the development of regulatory strategies and verification and validation requirements for new products and product changes to ensure compliance with applicable regulations and standards
• Monitor national regulatory requirements and relevant standards for continuous monitoring and respiratory therapies