Usability & Regulatory Affairs Specialist

3d3 days ago

Sentec

Lincoln, US · Full-time · $90,000 – $110,000

About this role

At Sentec, you will be passionate about advancing patient care through innovative medical technology. As a Usability & Regulatory Affairs Specialist, you will ensure products are safe, effective, and compliant with global regulations. This cross-functional role bridges human factors and regulatory strategy.

You will lead formative and summative usability studies, from protocol development to data analysis and reporting. You will develop usability engineering documentation per IEC 62366 and FDA guidance, including use specifications and risk analyses. You will also support regulatory submission dossiers and strategies for new products and changes.

You will collaborate closely with engineering, clinical, and quality teams to identify and mitigate use-related risks early. Working with external partners, you will drive design improvements based on study findings. The role is based in a rapidly growing company that values employee voices and recognizes hard work.

This position offers meaningful work that directly influences product quality and patient care worldwide. You will have opportunities for professional and personal growth in a supportive environment. Sentec emphasizes employee voices and recognizes hard work, making it a promising environment for career development.

Requirements

3+ years of experience in either human factors/usability or regulatory affairs in the medical device industry
Bachelor’s degree in biomedical engineering or related scientific or engineering background
Strong technical background and competency
Ability to understand basic operating principles, design, and the clinical use of complex electromechanical medical devices
Strong analytical skills and the ability to compile scientific/engineering data, and craft concise, precise, and persuasive narratives
Ability to travel as needed up to approximately five trips per year
In-depth knowledge of the medical device regulatory framework, with specific expertise in FDA requirements and familiarity with EU MDR 2017/745
Ability to understand, translate and/or speak German is a plus

Responsibilities

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
Support compilation of submission dossiers for new registrations and changes to existing approvals in close collaboration with internal and external stakeholders
Support 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

Benefits

Meaningful work in a rapidly growing company with opportunity for advancement
Directly influence the quality of products and make a difference for patients worldwide
Opportunities for professional and personal growth
The salary range for this position is $90,000–$110,000 plus bonus, commensurate with experience and credentials
Competitive benefits including Medical, Dental, Vision, HSA, FSA, 401K matching, paid parental leave, wellness stipend, and tuition reimbursement