Compliance & Regulatory Engineer/ (Medical Devices)

Key Responsibilities

• Coordinate and collaborate with external test laboratories for medical device compliance testing
• Develop, review, and maintain compliance test plans and reports
• Manage and release documentation through the company’s document control system
• Monitor and analyze updates to regulatory standards and ensure alignment
• Conduct regulatory and compliance impact assessments for new and existing products
• Work cross-functionally with internal teams and external test houses

Required Skills & Experience

• Strong experience in medical device compliance and regulatory testing
• Hands-on experience with test plan development and reporting
• Solid understanding of regulatory standards and compliance frameworks
• Experience working with external testing labs
• Knowledge of documentation control and release processes

Preferred Experience

• Background in manufacturing environments
• Experience with the following standards:

Radio / Wireless:

• EN 300 328
• FCC 15.247
• EN 301 489-1 / EN 301 489-17

Implantable Devices:

• ISO 14708-1
• ISO 14708-3

Non-Implantable Devices:

• IEC 60601-1
• IEC 60601-1-2

EMC / Immunity:

• IEC 61000-4 series