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RA Professional Market Expansion

Business Area:  QA/RA
Location: 

Ballerup, DK

Country:  Denmark
Employment type:  Full-time

Would you like to drive market expansion activities in Regulatory Affairs? And are you looking for an international job in a successful and growing MedTech company? Then Ambu might be your next career move.

 

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 and in a correct manner, Ambu is looking for a new colleague to join the Corporate Regulatory Affairs department.

 

As Regulatory Affairs Professional working from our Headquarters in Ballerup, you will work closely with colleagues from the different Regulatory Affairs functions both in the Sales Subsidiaries and at our Development and Manufacturing sites in China, Malaysia, Germany and the USA. As part of an organisation with short lines of decision-making, you will have a unique opportunity to influence the development of Regulatory Affairs in a company where quality is of great importance, and you will for sure be able to make your mark on Ambu’s growth. You will refer to Head of Corporate Regulatory Affairs Innovation.

 

Ensure company compliance with regulatory requirements
As Regulatory Affairs Professional, you will be supporting the market expansion registration work. You among others will help with optimise time to market for prioritised countries outside EU and USA by;

 

  • Participating in the prioritisation of registration activities based on strategy and market potentials
  • Liaising with and supporting regulatory affairs in Sales Subsidiaries and local Ambu RA departments
  • Ensure continuous development of work processes and documentation within Market Expansion process and work together with other process owners to optimise link between processes.
  • Contribute to incorporate prioritised RoW regulatory requirements in Ambu's products and processes enabling compliance to relevant national regulatory requirements

 

Due to the high level of collaboration with internal stakeholders, a high level of adaptability is required. You will be working closely with Customer Service, Subsidiaries, Corporate Marketing, and all RA departments within Ambu.

 

Assertive RA professional with good communication skills
If you have some experience within Regulatory Affairs, it will be an advantage but not a must. In terms of education, you must hold either a bachelor’s or a masters’ degree in the field of science or engineering.


Being able to work independently, being proactive and having experience with stakeholder management are key to success in this position. You are analytical, cooperative, and systematic. You are able to keep a clear overview in demanding situations. In addition, you turn challenges into opportunities, and you have a natural personal impact.

 

Given the international environment of Ambu, English is our corporate language. You will use English in your daily work, which requires that you speak and write English at 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.

 

When 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 31 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 Theresa Larriba Harboe, Head of Market Expansion, by phone + +45 2248 2705.

 

Your application will be treated with confidentiality.

 

#LI-AM1
 

About Ambu

Since 1937, breakthrough ideas have driven our work to bring efficient healthcare solutions to life within our fields of excellence: Anaesthesia, Patient Monitoring & Diagnostics and Emergency Care. Millions of patients and healthcare professionals worldwide depend and rely on the functionality and performance of our products. We are dedicated to improving 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 latest landmark solutions such as the aScope™ endoscope – the world’s first single-use flexible video scope. Our commitment to bringing new ideas and superior service to our customers has made Ambu one of the most recognised medico-technical companies in the world. Our head office is situated near Copenhagen in Denmark. Ambu employs approximately 4,500 people in Europe, North America, and the Asia Pacific. For more information, please visit www.ambu.com.