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Regulatory Affairs Professional
QA/RA

- Quality is the keyword!

Are you looking for independence in your job and a working day characterised by exciting new challenges? Would you like to be part of Ambu’s new product development groups and ensure that we meet all regulatory requirements? And are you looking for an international job? 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 skilled candidate to join the Corporate Regulatory Affairs department.

As Regulatory Affairs Professional, you will become part of a team, which consists of employees from Denmark China and Malaysia, with whom you will work closely. Corporate Regulatory Affairs is a part of Corporate QA & RA.

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.

Ensure company compliance with regulatory requirements
As Regulatory Affairs Professional, you will be responsible for ensuring compliance with regulatory requirements for products and processes.

Your primary responsibilities will be to:

  • Participate in development projects as a regulatory professional sparring partner
  • Contribute to the continual update of knowledge about regulatory requirements and contribute to incorporating these requirements in products and processes e.g. new EU-MDR
  • Contribute to incorporating current regulatory requirements in the quality system
  • Maintain and develop Regulatory Affairs Records, mainly in our Product LifeCycle Management System (Agile)
  • Support local Regulatory Affairs Departments in Asia
  • Ensure that Ambu's products and processes comply with relevant regulatory requirements – back-up on vigilance

Due to a high level of collaboration with internal stakeholders, a high level of adaptability is required. You will be working closely with the QA Engineering department, R&D, Corporate Marketing, Clinical Department, Corporate Business Analysis and other departments.

Assertive RA professional with good communication skills
As the preferred candidate you have 1- 3 years of experience with Regulatory Affairs from a regulated company or a regulatory body and you have experience with the EU directive for medical device and US-FDA requirement for design control.

Additionally, we expect that you have the ability and interest in reviewing new theories or laws and put them into practice. In terms of education, you must hold either a Bachelor’s or a Masters’ degree in the field of science.

Being able to work independently, being proactive and having experience in driving change management are key to success. In addition, you turn challenges into opportunities and you have a natural personal impact.

You must have an analytical and structured approach to your work and the capacity to prioritise in order to meet deadlines. Furthermore, you must poses 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 20 September 2017 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 Kaja Tengbjerg, Senior Manager, Corporate Regulatory Affairs, by phone +45 7225 2000.

Your application will be treated with confidentiality.

Please write in your application that you've seen the job at Jobfinder

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Arbejdssted
Ballerup
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Startdato
04. september 2017
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Slutdato
20. september 2017
phone
Kontakt
Kaja Tengbjerg
Tlf.: +45 7225 2000
work
Jobtype
Fastansættelse