Regulatory Affairs Professional

Regulatory Affairs Professional

City: Augsburg

Country/Region: Germany

State:

Business Area: Regulatory Affairs

Department: Regulatory Affairs, Endoscopy

Employment Type: Full-time

Req ID: 10376

Regulatory Affairs Professional

Ambu A/S is currently looking for a Regulatory Affairs Professional to be based in Augsburg.

You will join a strong team in Ambus Corporate Regulatory Affairs department, which currently consists of around 40 employees.

About the Team and Role

To meet increasing regulatory requirements and timelines, Ambu is looking for a candidate to join our Regulatory Innovation team for Endoscopy. You will be part of a highly skilled team of 8 people, reporting to the Head of Regulatory Affairs, Endoscopy.

At Ambu, collaboration is at the heart of everything we do. You will join a welcoming and supportive team where people enjoy sharing knowledge, helping each other succeed, and working together across functions and geographies. In this role, you will partner closely with colleagues in R&D, Quality, Clinical Affairs, Marketing, and Regulatory Affairs to bring innovative solutions to healthcare professionals and patients worldwide.

This position is based in Augsburg and offers a hybrid working model with three days per week on-site and two days working from home, providing flexibility while maintaining strong collaboration with your team and stakeholders.

As a Regulatory Affairs Professional, you will play a key role in ensuring regulatory requirements are integrated throughout the product development process. Acting as the Regulatory Affairs representative within cross-functional project teams, you will support both new product development projects and lifecycle management activities while helping to define and execute regulatory strategies that enable successful market access globally.

You will work closely with project teams to assess regulatory requirements across different markets, translate regulatory expectations into practical guidance, and ensure compliance throughout development. In addition, you will contribute to the preparation of regulatory submission documentation and technical files while supporting submissions in key markets such as the EU, US, and Canada.

Ambu is a collaborative and international organization where no two days are the same. You will collaborate with colleagues across Denmark, Europe, Asia, and the United States while helping shape the future of innovative endoscopy solutions.

Key Responsibilities

Your main responsibilities will include:

Act as the Regulatory Affairs representative in cross-functional project teams.

Support 2–3 new product development projects as well as lifecycle management activities.

Develop and implement regulatory strategies for new product development.

Provide regulatory support for innovation projects and drive regulatory strategies.

Engage in pre-submissions with FDA and interactions with regulatory authorities.

Prepare and compile regulatory submission documentation, technical files, and submission dossiers.

Manage submissions in the EU, US, and Canada, including timely responses to authorities to support fast approvals.

Assess regulatory requirements for different markets and ensure submissions meet country-specific regulations.

Translate regulatory requirements into practical guidance for project teams and ensure compliance throughout product development.

Provide regulatory input for lifecycle management activities.

Optimize regulatory processes and contribute to con