Regulatory Affairs Professional

In Augsburg, join Ambu’s Regulatory Innovation team for Endoscopy to ensure regulatory requirements are integrated throughout product development. You will act as the regulatory representative in cross-functional projects, shaping strategies for market access. You’ll support new product development and lifecycle activities, coordinating submissions for the EU, US, and Canada. The role offers hybrid work, collaborates with teams across geographies, and focuses on bringing innovative endoscopy solutions to healthcare professionals and patients.

• hybrid working model
• opportunities for professional development
• comprehensive employee benefits

• Act as the Regulatory Affairs representative in cross-functional project teams
• Support 2–3 new product development projects and lifecycle management
• 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 with timely responses to authorities
• 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
• Provide regulatory input for lifecycle management activities
• Optimize regulatory processes and contribute to continuous improvement initiatives within Regulatory Affairs

• Degree in Life Sciences, Engineering, Regulatory Affairs, or a related discipline
• Experience in Regulatory Affairs within medical device, MedTech, pharmaceutical, or other regulated industries
• Experience supporting product development projects in cross-functional environments
• Knowledge of global regulatory frameworks (MDR, FDA, Health Canada)
• Experience preparing regulatory submissions and technical documentation
• Strong communication skills to translate regulatory requirements into practical guidance
• Ability to manage multiple projects in a dynamic, international environment
• Structured, proactive, and solution-oriented mindset with collaboration focus
• Fluent English (written and spoken)

• strong communication
• cross-functional collaboration
• structured and proactive mindset
• Regulatory frameworks MDR, FDA, Health Canada
• Regulatory submissions and technical documentation
• Lifecycle management