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.

• 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 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

• 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

• 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