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Senior Regulatory Affairs Professional

Business Area:  QA/RA
Location: 

Ballerup, DK

Country:  Denmark
Employment type:  Full-time

Are you the go-to person when it comes to regulatory challenges and are you used to navigate the complex regulatory landscape for medical devices? Would you like to play a key role in maintaining Ambu’s continuous regulatory compliance of products and processes? And are you looking for a job with many international stakeholders? Then Ambu might be your next career move… 
 Ambu is a global company with ambitious growth targets and an exciting and growing product portfolio. Our ability to identify and adapt to the evolving regulatory landscape is essential for continuous growth within our business areas. Therefore, Ambu is looking for a Senior Regulatory Affairs Professional to take part in ensuring continuous compliance in Ambu. As a Senior Regulatory Affairs Professional, you will become part of a team, which consists of employees from Denmark, Germany, USA, China and Malaysia, with whom you will work closely.
 
Ensure company compliance with regulatory requirements.   

As part of an organisation with short lines of decision-making, you will have a unique opportunity to influence the development of Regulatory Affairs and set the strategic direction and framework for us to comply within the different regulations. You will have a broad and holistic overview of the regulatory requirements and put it into practice by empowering both RA professionals and other relevant parts of the organization. This is done by acting as sparring partner to the rest of the RA team, updating regulatory procedures, communication of regulatory requirements and strategies and by knowledge sharing e.g. by chairing workshops. Communication is therefore a key part of your assignments.  

 

Your primary responsibilities will be to:

  • Act as a regulatory sparring partner for RA colleagues in relation to sustaining management of approved products to ensure regulatory compliance and alignment across all products and processes
  • Ensure Ambu successfully implements new medical device legislation by setting the strategic direction and framework
  • Provide guidance to global regulatory strategies and empower company and project decisions
  • Act as regulatory partner in projects and process updates related to partnerships and sourcing.
  • Provide guidance in relation to partnerships and sourcing (regulatory roles) for RA colleagues and other parts of the organization
  • Provide regulatory support in relation to changed regulations e.g. Brexit and continued market access in UK
  • Take part in the regulatory intelligence process
  • Provide guidance as well as participate in maintenance of technical files for marketed products and provide regulatory support for product changes. 
  • Corporate support and sparring to local regulatory affairs departments at our manufacturing and innovation sites 
     


You will join the Corporate Regulatory Affairs department within the RA Operation team, but you will work close with the rest of the Corporate Regulatory Affair department and with the QA-Engineering department, local regulatory affairs departments at our manufacturing sites, R&D, Marketing, and other departments.
 
Pro-active and positive RA professional with good communication skills
It is a requirement that you have minimum 4+ years years of experience with Regulatory Affairs from the medical device industry. It will be an advantage that you have a global outlook regarding device legislation and knowledge of regulatory roles and responsibilities in partnerships across jurisdictions (economic operators). Experience working with ISO 13485, design control, labelling and risk management will be a plus. In terms of education, you must hold either a bachelor’s or a Masters’ degree in the field of science.
You can find solutions by taking a deep dive into regulations and guidelines when needed. To support decision making, you can communicate requirements and solutions in a clear matter and can navigate many agendas and stakeholders. We want you to share your knowledge and take lead. In addition, you must have an analytical and structured approach to your work and the capacity to priorities in order to meet deadlines.
 
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 18th of April 2021 but once we have found the right candidate, this add will no longer be online. 
 
If you have any questions about the position, you can contact Katrine Dalsgaard Ajbro, Head of Regulatory Affairs Operation, by phone +45 26779750.
 
Your application will be treated with confidentiality.

 

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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 4,200 people in Europe, North America, and the Asia Pacific. For more information, please visit www.ambu.com.

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