Compliance Engineer (m/f/d)

Your mission

• 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.
• Manage and execute conformity testing in the following areas:
• 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.
• 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.
• 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.

Your profile

• Bachelor’s or Master’s degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or a related technical discipline with a strong focus on product compliance.
• Minimum of 5 years of proven professional experience in medical device development or compliance engineering.
• In-depth understanding of relevant IEC standards for medical electrical equipment (ME equipment):
• Hands-on experience with ALM tools (e.g., Codebeamer, Polarion, DOORS).
• Solid knowledge of EMC and electrical safety principles.
• Strong proficiency in systems engineering and requirements management.
• Extensive experience with technical documentation and design control processes.
• Professional fluency in English (written and verbal) for international collaboration with regulatory bodies and test laboratories (German language skills are a plus).
• Strong analytical capabilities and a solution-oriented mindset.
• Ability to precisely interpret complex standards and regulatory requirements.
• Excellent communication and stakeholder management skills.
• Ability to constructively and objectively challenge design decisions based on data.
• Team player who thrives in an interdisciplinary, collaborative environment.
• Self-motivated, structured, and detail-oriented work ethic.

Why us?

• Personal induction plan and comprehensive onboarding
• Flexible working hours
• 30 days of holiday
• interesting tasks in a dynamic, international environment
• Continuous training and development
• Flat hierarchies
• Attractive canteen
• Free coffee, tea and water
• Employee events
• Charging stations for electric cars
• Accident insurance
• Employer contribution to VWL
• Employee fund with various allowances and subsidies
• Free language courses