Sentec

Usability and Regulatory Affairs Specialist

Lincoln, Rhode Island, United States

Sponsorship not specified$90k-$110kDetected 44 days ago

Data AnalysisPatient CareFDA RegulatoryMedical DevicesCollaborationRegulatory Affairs

About the role

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.

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

Sentec emphasizes employee voices and recognizes hard work making it a promising environment for professional growth.
Sentec focuses on delivering impactful healthcare products and improving patient care.
Sentec is a Swiss-American medical device company specializing in respiratory care.
Sentec provides healthcare professionals worldwide with non-invasive, continuous monitoring and effective therapeutic solutions.

Since its founding in 1999, Sentec utilizes a deep-tech approach that is founded on advanced science and avant-garde technologies for respiratory patients across care areas.

This listing is sourced directly from Sentec's careers page and normalized into a canonical job model.