Regulatory & Lifecycle Compliance Specialist

Job summary

The role involves ensuring compliance of hearing aid products throughout their lifecycle, supporting regulatory assessments, product changes, and process improvements. The position is ideal for someone early in their career who enjoys structured problem-solving and collaboration across functions.

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 in 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 to support product development and lifecycle improvements
• Identify opportunities for automation and process efficiency
• Prepare and maintain regulatory documentation

Skills

• Familiarity with automation or digital tools (e.g., Python, Power Automate, Power BI)
• Interest in AI tools for efficiency and process improvement
• Experience with Agile or Scrum methodologies

Education

• Degree in Engineering or relevant technical field

Tools

• Regulatory frameworks (MDR, FDA, ISO 13485, IEC 62304, IEC 62366)
• Digital tools for automation and process improvement