Verification & Validation Engineer / Regulatory Compliance Medical Devices (m/w/d)

Your mission
Job Summary
As a Verification &
Validation Engineer / Regulatory Compliance Medical Devices (m/w/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 with the IEC 60601 series as well as MDR and FDA requirements.
• Monitor updates to relevant standards and conduct delta analyses to assess their impact on products.

b) Verification and Validation
• Manage and execute conformity testing in the following areas:
o Electrical safety
o Electromagnetic compatibility (EMC)
o Functional safety
o Software Lifecycle Compliance
• Coordinate and communicate directly with external, accredited test laboratories.
• Create and evaluate test plans and test reports regarding potential compliance deviations.
• Independently resolve regulatory and technical issues during certification testing.

c) Product Development Support
• Collaborate closely with system architects and engineering teams during the concept, design, and verification phases.
• Ensure that all compliance activities are seamlessly integrated into the product development process.
• Review system requirements, architecture, interfaces, and design documentation.

Additional Responsibilities:
• Take ownership of change impact analyses to evaluate the regulatory and normative impact of product changes.
• Conduct training sessions and provide guidance to development teams regarding standards and compliance best practices.
• Actively contribute to regulatory strategy discussions for new products and global market clearances.