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Clinical Research Specialist, Post Market Clinical Development

Business Area:  Clinical Research
Location: 

Ballerup, DK

Country:  Denmark
Employment type:  Full-time

Do you enjoy working with clinical documentation and research for medical devices? And are you ready to take responsibility, develop and implement the clinical activities for our medical devices? 
 
At Ambu, we develop, produce and sell medical devices, enabling healthcare professionals to save lives and improve patient care around the world where you will be instrumental in securing our ongoing dedication to quality products. 
As we continue to expand our Post Market Clinical Development (PMCD) team you willl participate in securing our ongoing dedication to quality products. You will be part of an innovation culture with which means that there is a visible link between your results and Ambu’s growth. The position is based at Ambu’s headquarter in Ballerup, Denmark and this is a new vacancy as part of our continued expansion of PMCD at Ambu.

 

Key Responsibilities 

In this position, you play an important role in a wide range of clinical activities related to market entries, expansions and the post market product phase. Your main focus will be to provide cross functional clinical support and documentation for a range of our products and related activities. This includes planning, driving and executing clinical development, documentation and product expansion activities as well as maintenance and study activities.

 

•    Take ownership and responsibility as global post market clinical responsible for a range of products from market launch and throughout the product lifecycle.  
•    Develop and maintain the clinical documentation for a range of products. 
•    Be a proactive clinical sparring partner in development, expansion, maintenance and improvement activities.
•    Support and continuously improve the strengthening of the clinical commercial foundation for our marketed products within the clinical indication areas.
•    Balance your clinical scientific interest with a hands-on approach in activities as you drive, develop and maintain the clinical documentation and post market clinical follow-up activities. 
•    Be a trusted clinical post market partner in our global organization.

 

You will work closely together with our colleagues in Global Clinical Affairs, Global Innovation, Marketing and Sales ensuring ongoing support and development of high-quality products. You will work in an interdisciplinary position with various external and internal stakeholder.

 

Key Competences

You are experienced in developing and maintaining Clinical Development Plans, Clinical Evaluation Reports and Post Market Clinical Follow Up Plans and Reports for medical devices both with and without software. In addition, you are able to proactively develop and handle the post market clinical follow-up strategies incl. study activities for a specified product range as well as provide support for commercial studies.

 

You have a clinical and medical device understanding/background and hold an academic degree, e.g. a MSc in Health or similar. You may have +3 years of experience working with medical devices and related clinical documentation preferably from the medical device industry. 

 

You are well versed in EU and FDA regulation and guidelines related to medical devices and clinical indication areas and can explore, develop, present and execute strategic and operational clinical angles with a global mindset.

As a person, you enjoy working in a growth environment and have a structured mindset with a “can do” attitude. You meet deadlines both individually and together with your colleagues. You have excellent communication skills and thrive in providing clinical guidance, making accurate judgements and have a natural desire to drive continuous improvement. 

 

Finally, you also have an excellent command of the English language, as this will be your main working language both verbally and in writing. 

 

Information and when to apply
If you are interested in the position, then please apply as soon as possible. For additional information or questions, please contact Pia Juul Würtz, Head of Post Market Clinical Development, Global Clinical Affairs on telephone +45 7225 2000. Your application will be treated with confidentiality.

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.