Senior Regulatory Affairs Professional with strong skills in software regulation

Ambu is a global company with ambitious growth targets. Our ability to identify and develop innovative products is essential for continuous growth within our business areas. To be able to meet the increasing regulatory requirements on time, Ambu is looking for a skilled candidate to join the Corporate Regulatory Affairs department within our RA Innovation team. You will be an extension to a rapidly growing team as we have an ambitious plan to develop 30 new products during the next couple of years, you will get lots of opportunities to develop in your new role. 

Ensure regulatory compliance in Ambu’s Innovation projects
As part of an organisation with short lines of decision-making, you will have a unique opportunity to influence the development of new products within regulatory affairs in a company where quality is of great importance. Here you will be responsible for ensuring compliance and giving guidance in our development teams for Ambu’s future product development. 

Your primary responsibilities will be to:

• Participate in development projects as a regulatory affair partner
• Be fully updated about regulatory requirements for developing new technologies with focus on Ambu’s visualization devices and displaying units
• Defining the RA strategy for products to maintain our fast-to-market approach.  
• Contribute to that Ambu successfully implements new EU and US medical device regulation and guidance.

You will be working closely together with our innovation project teams and therefore be collaborating with people from QA-Engineering department, R&D, Corporate Marketing, Clinical Department and other departments to develop our new products. 

Assertive Senior RA professional with good communication skills
It is a requirement that you have minimum 5 experience with Regulatory Affairs from the medical device industry and that you have experience with the EU Directive, knowledge about the new EU Regulation for medical device and US-FDA requirement for design control. You also have a good understanding of the 510(k)-process. Besides that, you have the ability and interest in reviewing a new theory or law and put it into practice. In terms of education, you must hold either a Bachelor’s or a Masters’ degree in the field of science.

To succeed in the job, you are able to work independently, being proactive and having experience in driving change management. Furthermore, you must hold excellent communication skills including speaking and writing English on a high level.
 
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 a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.

How to apply
If you are ready to apply for the position, please apply as soon as possible. Note that we will invite candidates for interviews on a continuous basis so no need to hesitate. This job ad might be online until 25th of October 2020 but once we have found the right candidate, this ad will no longer be online.

If you have any questions about the position, you can contact Kristine Rasmussen, Head of RA Innovation, by phone +45 51810901

Your application will be treated with confidentiality.

About Ambu
Since 1937, breakthrough ideas have fuelled our work on bringing efficient healthcare solutions to life. This is what we create within our fields of excellence – Anaesthesia, Patient Monitoring & Diagnostics, and Emergency Care. Millions of patients and healthcare professionals worldwide depend on the functionality and performance of our products. We are dedicated to improve patient safety and determined to advance single-use devices. The manifestations of our efforts range from early inventions like the Ambu Bag™ resuscitator and the legendary BlueSensor™ electrodes to our newest landmark solutions like the Ambu aScope™ – the world’s first single-use flexible endoscope. Our commitment to bringing new ideas and superior service to our customers has made Ambu one of the most recognized medical companies in the world. Headquartered near Copenhagen in Denmark, Ambu employs approximately 3,100 people in Europe, North America and the Asia Pacific. For more information, please visit www.ambu.com

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