Job Description
Your mission
Job Summary
As a Compliance Engineer (m/f/d), you will work closely with all R&D departments and Regulatory Affairs. In this role, you will analyze, interpret, and review regulations and standards to ensure ongoing compliance of our medical devices, software solutions, and processes. You will support our products throughout their entire lifecycle, from initial concept and development to market launch. In addition, you will translate normative requirements into technical specifications and coordinate all compliance activities with external test laboratories and regulatory authorities.
Key Responsibilities:
a) Standards & Regulatory Compliance
• Identify relevant international standards and regulatory requirements for medical devices.
• Interpret and translate standards into actionable system and engineering requirements.
• Create and maintain standards matrices, applicability matrices, and compliance checklists.
• Ensure compliance wi...