Are you passionate about tackling regulatory challenges? Do you enjoy leading a team of talented regulatory affairs professionals and transforming complex regulations into actionable frameworks?
If you're committed to continuous improvement and excited about contributing to innovative global R&D projects, this could be your defining moment. Apply today and embark on a rewarding career with us!
Why Ambu?
At Ambu, we are pioneers in the medical device industry, committed to advancing patient care worldwide. As a Senior Regulatory Affairs Visualization Manager, you will play a vital role in supporting our product innovation.
You'll join a team of 12 Regulatory Affairs Professionals located in Ballerup, Denmark, and Augsburg, Germany, reporting to Head of Regulatory Affairs Endoscopic Solutions, Kristine Rasmussen .
This role offers the flexibility to be based in either Ballerup or Augsburg.
Key responsibilities
You will lead a team of Regulatory Affairs Specialists working on both new product development projects and throughout product lifecycle. You'll be a key member of our ambitious and collaborative RA team where you'll have the unique opportunity to shape Ambu's regulatory strategy.
Your main responsibilities will include:
- Guide and support a talented team of Regulatory Affairs Professionals to continuously develop individuals within your team
- Drive regulatory strategy across product development projects
- Ensure effective communication with authorities, including submissions for product clearance
- Collaborate across functions and sites to provide timely, coherent, and robust regulatory support, identifying potential risks and proposing mitigation strategies
Suggested candidate profile
As a Regulatory Affairs manager, you are present, visible, and curious. You are not afraid to set direction and drive cross-functional teamwork.
Skills can be earned in different ways; however, we imagine your background includes:
- A relevant academic background in life sciences, engineering, pharmacy, or a related field, with at least 5 years of experience from Medical Devices or Pharma.
- Management experience with a least 2 years of leading others, engaging in honest conversations, and providing contructive feedback.
- An in-depth understanding of regulatory compliance frameworks such as MDR, FDA, and ISO 13485.
- An outgoing personality with strong business understanding, excelling in communicating regulatory requirements and facilitating effective implementation within a global organization.
- Self-driven and comfortable taking the lead, while valuing collaboration, being open-minded, and adapting well to dynamic and fast-paced environments.
It is essential that you have excellent communication skills in English, both written and oral, and that you are willing to travel up to 20 days per year when feasible and safe. In this position you are allowed to work from home up to 1-2 days per week.
Apply now
Are you ready to make a global impact and help shape the future of medical technology at Ambu? The Talent Attraction team will engage with candidates on an ongoing basis, so we encourage you to apply without hesitation! Questions? Reach out to Head of Regulatory Affairs Endoscopic Systems, Kristine Rasmussen at krra@ambu.com
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.