Regulatory Affairs Professional
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, you will work closely with colleagues from the 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.
Ensure company compliance with regulatory requirements
As Regulatory Affairs Professional, you will be supporting the departments activities within Market Expansion registration, where you among others will help with optimise time to market for prioritised countries outside EU and USA by;
- Leading prioritisation of registration activities based on strategy and market potentials
- Liaising with and supporting to 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 a high level of collaboration with internal stakeholders, a high level of adaptability is required. You will be working closely with Sales, Corporate Marketing, R&D, QA-Engineering and other departments.
Assertive RA professional with good communication skills
In terms of education, you must hold either a bachelor’s or a masters’ degree in the field of science or engineering. Experience with Regulatory Affairs and with registration activities outside of EU and USA would be an advantage, but not a requirement.
Being able to work independently, being proactive and having experience in driving your area of responsibility are key to success in this position. You are analytical, cooperative and systematic, and you are able to have a clear overview in demanding situations. In addition, you turn challenges into opportunities, and you have a natural personal impact.
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.
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 20 September 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, Senior Market Expansion Manager, by phone + +45 2248 2705.
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 4,200 people in Europe, North America and the Asia Pacific. For more information, please visit www.ambu.com
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