Lead Usability Engineer, Regulatory Ops — Flexible Work

Freelio; Denmark; Remote; DKK 700,000 - 1,100,000; Full time

Job summary

GN Hearing A/S is seeking a Lead Usability Engineer in Regulatory Operations to drive compliance for new product development, lead usability processes, and support regulatory submissions. You will act as the lead usability SME, collaborating with cross‑functional teams to ensure user‑centered design meets IEC 62366 and related guidance.

The role emphasizes stakeholder engagement, English communication, and driving improvements across the development lifecycle within a dynamic hearing device

Qualifications

• Experience in usability engineering within a medical device environment.
• Solid understanding of regulatory guidance for usability.
• Ability to influence stakeholders with varying levels of regulatory knowledge.

Responsibilities

• Drive regulatory product compliance in usability engineering for new product development.
• Establish, maintain, and improve usability processes and documentation across the product lifecycle.
• Act as lead usability specialist and subject‑matter expert.
• Support regulatory submissions, audits and authority responses related to usability and human factors engineering.

Skills

Regulatory usability engineering

IEC 62366 knowledge

Stakeholder communication

Education

Engineering degree or related field

Tools

Regulatory frameworks

Job description

GN Hearing A/S is seeking a Lead Usability Engineer in Regulatory Operations to drive compliance for new product development, lead usability processes, and support regulatory submissions. You will act as the lead usability SME, collaborating with cross‑functional teams to ensure user‑centered design meets IEC 62366 and related guidance.

The role emphasizes stakeholder engagement, English communication, and driving improvements across the development lifecycle within a dynamic hearing device