Head of Regulatory Machines, Water Systems & Digital

at  Fresenius Medical Care

We are seeking a dynamic Head of Regulatory Machines, Water Systems & Digital (m/f/d) to lead our regulatory efforts for our cutting-edge active medical devices and water systems. As a pivotal leader, you will ensure compliance, manage product registrations, and support design and development initiatives globally.

Overall Responsibilities:

• Communication and collaboration with various departments and stakeholders.
• Process optimization and monitoring of regulatory compliance.
• Providing regulatory input and guidance for documentation and project teams.

Regulatory Documentation:

• Creation and maintenance of regulatory product documentation.
• Role of Product Center Manager in regulatory aspects.
• Support for design projects and assessments.
• Preparation of technical documents for clinical evaluations.

Product Registration:

• Ensuring product availability in global markets.
• Coordination of regulatory activities and submissions.
• Registration of medical devices and production sites.
• Support for pharmaceutical registrations and tender processes.

Change Management:

• Participation in design change councils and approval processes.
• Evaluation and implementation of product/process changes.

Creation/Review/Approval:

• Declarations of conformity and creation of product center information.
• Support for supplementary requests and marketing materials.