Usability and Regulatory Affairs Specialist

About the role

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. This cross-functional role involves leading human factors and usability engineering activities while also supporting regulatory submissions and strategy.

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 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

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
• The 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
• The ability to understand, translate and/or speak German is a plus

Qualifications/Education

• Preferred: In-depth knowledge of the medical device regulatory framework, with specific expertise in FDA requirements and familiarity with EU MDR 2017/745
• Strong technical background and competency
• Bachelor's degree in biomedical engineering or related scientific or engineering background

Benefits

• Salary range: $90,000-$110,000 plus bonus, commensurate with experience and credentials
• Competitive benefits: Medical, Dental, Vision, HSA, FSA, and 401K matching
• Paid parental leave
• Wellness stipend and tuition reimbursement

Schedule

Directly influence the quality of products and make a difference for patients worldwide

Pay

$90,000-$110,000 plus bonus, commensurate with experience and credentials

Benefits

• Medical
• Dental
• Vision
• HSA
• FSA
• 401K matching
• Paid parental leave
• Wellness stipend
• Tuition reimbursement