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 Regulatory Affairs Operational team and ensure that Ambu meet all regulatory requirements related to vigilance? 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 a Vigilance Specialist, you will become part of a team, which consists of employees from Denmark, Germany, USA, 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 vigilance process in a company where quality is of great importance.
Ensure company compliance with regulatory requirements
As Vigilance Specialist, you will be responsible for ensuring compliance with regulatory requirements related to vigilance, ensuring timely communication with authorities and you will play an important role in the post market surveillance processes.
Your primary responsibilities will be to drive and ensure:
- Timely reporting of reportable incidents and FSCA’s to authorities
- Daily evaluation of complaints and CA/PA for reportability
- That Ambu successfully implements new EU, Canada and US requirements for vigilance and has fully updated knowledge about regulatory requirements for medical device reporting.
- Coordination, communication and record keeping in case of Field Safety Corrective Actions
- Contribute to incorporate current regulatory requirements in the quality system and ensuring that Ambu’s products and processes comply with relevant regulatory requirements
- Maintain and develop of Regulatory Affairs records including corporate support to local regulatory affairs departments at our manufacturing and innovation sites.
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 both in Denmark and abroad, R&D, Corporate Marketing, Clinical Department, Corporate Business Analysis and other departments.
Assertive professional with good communication and cooperation skills
It is a requirement that you have minimum 3-5 years of experience with Vigilance or Regulatory Affairs from the medical device industry and that you have experience with both the EU- and US medical device legislation. Experience working with vigilance, post market surveillance and risk management will be an advantage. 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.
Being able to work independently and structured, being proactive and exhibiting flair for stakeholder 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 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 28 May 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 Katrine Dalsgaard Ajbro, Senior Regulatory Affairs Professional, by phone +45 26779750.
Your application will be treated with confidentiality.
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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