Global Regulatory Process Lead

Ambu A/S; Ballerup Kommune; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

Ambu A/S is seeking a Global Process Lead – Regulatory Affairs at our headquarters in Ballerup, Denmark. The role centers on shaping and developing regulatory processes across the product lifecycle and enabling the rollout of a new Product Lifecycle Management system.

You will collaborate with stakeholders worldwide to ensure documentation, systems, and data support regulatory requirements. The role emphasizes process ownership, audits, and strong cross-functional coordination to maintain

Qualifications

• Relevant academic degree in Life Sciences, Engineering, or similar.
• Experience with regulatory processes across product lifecycles in regulated industries.
• Experience with process ownership and development in regulated environments.

Responsibilities

• Act as Process Owner for regulatory processes across the product lifecycle.
• Support transition to a new Product Lifecycle Management system.
• Ensure processes are effective, aligned, and fit for purpose across functions.
• Identify dependencies, gaps, and drive improvements across stakeholders.
• Participate in audits and explain process governance and implementation.

Skills

Regulatory processes

Process ownership

Stakeholder management

Analytical thinking

Clear communication

Education

Relevant academic degree (Life Sciences or Engineering)

Job description

Ambu A/S is seeking a Global Process Lead – Regulatory Affairs at our headquarters in Ballerup, Denmark. The role centers on shaping and developing regulatory processes across the product lifecycle and enabling the rollout of a new Product Lifecycle Management system.

You will collaborate with stakeholders worldwide to ensure documentation, systems, and data support regulatory requirements. The role emphasizes process ownership, audits, and strong cross-functional coordination to maintain