Senior Regulatory Affairs Specialist - US

Ambu A/S is currently looking for a Senior Regulatory Affairs Specialist to be based in Columbia, MD, US. As a Senior Regulatory Affairs Specialist, you will be responsible for enhancing our regulatory presence in the US and strengthening relationships with the FDA and other regulatory bodies. This role requires a proactive professional with deep regulatory insights, strong networking capabilities, and a talent for gathering strategic information. The position involves approximately 15-20 travel days annually, primarily within the US.

Key Responsibilities

Your main responsibilities will include:

• Advamed Engagement: Participate in various Advamed working groups, channeling insights back to the organization and contributing to policy development
• FDA Intelligence: Stay informed by monitoring regulatory news and participating webinars, town halls, and conferences
• FDA Interactions: Lead informal discussions related to submissions, participate in Q-Submission meetings, and engage in Breakthrough and STeP dialogues. Maintain contact with the FDA Ombudsman
• Conferences & Trade Shows: Represent the company at US-based conferences to network, engage with stakeholders, and stay updated on emerging technologies and competitor activities
• Networking: Build and maintain a strong regulatory network within the US medical device community
• Analysis & Research: Conduct in-depth analysis of the FDA 510(k) database, track competitor submissions, and monitor Breakthrough, STeP, and De Novo clearances relevant to our portfolio
• Strategic Input: Provide actionable regulatory and business insights to support compliance and strategic initiatives
  
  

You will collaborate closely with regulatory development teams in Denmark and Germany.

Suggested candidate profile

Skills

Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:

• Education: Bachelor’s or Master’s degree in Life Science, Pharmacy, Engineering, or a related field
• Experience: Minimum 10 years of regulatory affairs experience in the US medical device industry, including direct FDA interactions
• Regulatory Expertise: Strong understanding of the US regulatory landscape for medical devices and the ability to apply new knowledge in an organizational context
• Relationship Building: Excellent interpersonal and communication skills, with a proven ability to collaborate across geographies
• Strategic Thinking: Ability to align regulatory strategy with business goals
• Communication: Skilled in articulating complex regulatory issues with the organization and leading discussions with regulatory authorities
• Adaptability: Comfortable working in a fast-paced, dynamic environment with multiple priorities
  
  

Ambu – a visionary and international workplace where your efforts matter

Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.

We offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.