Global Regulatory Process Lead

Ambu; Ballerup; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

Ambu, headquartered in Ballerup, Denmark, seeks a Global Process Lead for Regulatory Affairs to shape regulatory processes across the product lifecycle. You will drive alignment with stakeholders worldwide and contribute to implementing a new Product Lifecycle Management system.

You will interact with global teams to ensure regulatory requirements are embedded in how we work, from labeling to product registration and regulatory intelligence.

Qualifications

• Regulatory Affairs experience in a regulated industry (medical devices or pharma).
• Strong understanding of regulatory processes across the product lifecycle.
• Experience with process ownership and development in regulated environments.
• Ability to shape and improve complex regulatory processes with cross-functional alignment.
• Basic understanding of systems and data flows that support regulatory processes.
• Strong stakeholder management and ability to align across functions.
• Structured, pragmatic approach with analytical and communication skills.
• Fluent in English (written and spoken).

Responsibilities

• Act as Process Owner for the relevant regulatory process and ensure it supports regulatory requirements.
• Maintain effectiveness and fit for purpose during transition to a new lifecycle management system and identify improvements.
• Develop and maintain relevant QMS documentation, ensuring consistency with process requirements.
• Identify dependencies, gaps, and alignment across functions and lifecycle stages.
• Collaborate with SMEs and Global Process Owners to align processes, interfaces, and data needs.
• Participate in audits as Process Owner and explain governance and maintenance practices.
• Support workshops, training, and change management to ensure understanding and application.

Skills

Regulatory affairs

Process ownership

Stakeholder management

Lifecycle understanding

Analytical skills

Education

Life Sciences or Engineering degree

Tools

Product Lifecycle Management (PLM) system

Job description

Ambu, headquartered in Ballerup, Denmark, seeks a Global Process Lead for Regulatory Affairs to shape regulatory processes across the product lifecycle. You will drive alignment with stakeholders worldwide and contribute to implementing a new Product Lifecycle Management system.

You will interact with global teams to ensure regulatory requirements are embedded in how we work, from labeling to product registration and regulatory intelligence.