Regulatory & Lifecycle Compliance Specialist

Job summary

In this role, you will ensure compliance of hearing aid products throughout their lifecycle, supporting regulatory assessments, product changes, and process improvements. You will work collaboratively within a team to bring safe and compliant medical devices to market.

Qualifications

• Degree in Engineering or a relevant technical field
• Relevant experience from studies, internships, or early-career positions
• Interest in medical device regulation and quality, with familiarity with frameworks such as MDR, FDA, ISO 13485, IEC 62304, or IEC 62366
• Understanding of procedures, controlled documentation, change control, and audit-ready processes
• Structured and risk-based approach to work
• Clear communication skills, adaptable to different audiences
• Ability to work independently and collaboratively
• Curiosity, analytical mindset, and motivation to learn
• Proficiency in English, both written and spoken

Responsibilities

• Support regulatory compliance activities for hearing aid products
• Contribute to regulatory assessments and product change activities
• Collaborate with colleagues across functions for product development and lifecycle improvements
• Identify opportunities for automation and process improvement using digital tools and AI
• Prepare and maintain regulatory documentation

Skills

• Familiarity with automation or digital tools, such as Python, Power Automate, or Power BI
• Interest in Agile or Scrum methodologies

Education

• Degree in Engineering or a relevant technical field

Tools

• Digital tools for automation and process improvement