Regulatory Certification Engineer

Job summary

This role involves collaborating with colleagues and external stakeholders to facilitate market access for hearing aid products. The position is part of the Regulatory Certifications Team within Corporate Quality, focusing on ensuring compliance with applicable standards and regulations.

Qualifications

• Bachelor’s or Master’s degree in natural science or engineering.
• Experience with medical devices and radio equipment, including knowledge of relevant directives and standards such as Radio Equipment Directive, EMC directive, and MDR.

Responsibilities

• Oversee and manage Type Approvals and Special Certifications.
• Provide input to regulatory strategy by identifying applicable standards for RF, EMC, and safety testing.
• Collaborate with engineers and project managers to ensure product compliance through testing.
• Manage the type approval process, including engaging external test labs and preparing test plans.
• Coordinate Special Certifications for Bluetooth, Apple, and Google.

Skills

• Attention to detail and ability to manage multiple projects simultaneously.
• Proactive approach to project management and continuous improvement.
• Strong communication skills in English, both spoken and written.

Education

• Bachelor’s or Master’s degree in a relevant field.

Tools

• Familiarity with testing and certification processes for medical devices.