Global Medical Device Usability & Regulatory Lead

Sentec; Lincoln (RI); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, vision

HSA & FSA

401K matching

Paid parental leave

Tuition reimbursement

Job summary

Sentec, a Swiss-American medical device company focusing on respiratory care, seeks a Usability and Regulatory Affairs Specialist to ensure products are safe, effective, and compliant globally. You will lead human factors activities and support regulatory submissions with engineering, clinical, and quality teams.

You will plan usability studies, maintain documentation, and drive risk mitigation. You will monitor FDA/EU requirements for continuous compliance and may travel up to five times per

Qualifications

• 3+ years in human factors/usability and/or regulatory affairs in medical devices.
• Bachelor's degree in biomedical engineering or related field.
• Strong analytical skills and ability to craft concise narratives.
• Willingness to travel up to five trips per year.

Responsibilities

• Plan and conduct formative and summative usability studies per regulatory expectations.
• Develop usability documentation: use specs, task analyses, risk analyses.
• Collaborate to identify use-related risks and drive design improvements.
• Support submission dossiers for new registrations and changes.
• Contribute to regulatory strategies and verification/validation requirements.
• Monitor regulatory requirements and standards for respiratory therapies.

Skills

Human factors

Regulatory affairs

Biomedical engineering

Analytical skills

Education

Biomedical engineering

Job description

Sentec, a Swiss-American medical device company focusing on respiratory care, seeks a Usability and Regulatory Affairs Specialist to ensure products are safe, effective, and compliant globally. You will lead human factors activities and support regulatory submissions with engineering, clinical, and quality teams.

You will plan usability studies, maintain documentation, and drive risk mitigation. You will monitor FDA/EU requirements for continuous compliance and may travel up to five times per