Technical Regulatory Affairs Employee

Are you passionate about ensuring safety and quality?

 

Do you enjoy navigating regulatory standards and managing product compliance?

 

Join our innovative client and play a crucial role in ensuring their devices meet all regulatory requirements and safety standards.

 

This position is ideal for someone with an engineering background, with a solid understanding of regulatory requirements who thrives in a detail-oriented, cross-functional environment!

 

Key Responsibilities:

• Identify and interpret compliance standards for our products.
• Assess standard updates and determine necessary adjustments with relevant departments.
• Develop product specifications for new products based on industry standards.
• Oversee approvals and maintain certifications by collaborating with both internal teams and external authorities.
• Work closely with certification agencies (e.g., UL, TÜV) to meet industry requirements.
• Plan, coordinate, and conduct risk assessments for our medical devices (including electronic components and software).
• Support product development in defining and validating risk-reducing measures.
• Schedule and perform routine reviews of risk assessments.

 

Requirements:

• Bachelor's degree in Engineering e.g. Electrical Engineering or equivalent technical training with relevant professional experience.
• Familiarity with regulatory requirements for medical devices or electronic appliances.
• Excellent communicator and team player who enjoys interfacing between development and regulatory compliance.
• Fluency in German and English.

 

If you're interested in this position, please apply and/or contact Hollie Dear at Adaptive Life Science for more information.