Senior Design Control Specialist

Are you excited by influencing how we as an innovation company work efficiently and value creating with design and development processes? Do you have experience from product development companies working with international standards and regulatory requirements for medical devices? Would you like to be part of contributing to an ambitious strategy for innovation of new medical devices? Then we have an exciting job opportunity for you. 

About the team 
You will be part of a small newly established Innovation Process team, which merges two related areas: keepers of the Design Control and Design Change processes, and the Project Management Office for our innovation portfolio.  

In Ambu we have a global innovation culture across multiple sites. And we have a tradition for fast completion of projects and focus on developing new products and production that combines several technologies in new and innovative ways. The Innovation Process Team is supporting this by driving the agenda of improving our ways of working across project management, development and MDR/Design Control processes. This among other means that we are focusing on ensuring coherent and meaningful processes as well as implementing and supporting the organization to adapt and adhere to this. 

About the role 
We are currently looking for an experienced Sr Design Control Specialist to become part of the journey.  

As Senior MDR/Design Control Specialist, you will be a key player in helping us mature our ways of working within MDR/ Design Control. Your work will include continuous improvement and optimization of Design Control and Design Change processes and be up to date with current regulatory standards for the development of medical devices. The role will work together with a wide range of stakeholders locally and globally to ensure coherent processes aligned with Risk Management and Usability. 

A part of the role is also to ensure internalization of our process with training and coaching of the different stakeholders and roles in the development. The key for us is that this will not only be focused on the how to do, but also putting it into context of what we are doing and why. We are looking to support the processes and training, with e.g. user guides, tips and tricks where relevant.  

Your stakeholders will be both within our innovation organization, but also the cross functional projects teams as well as other supporting functions like Regulatory Affairs, Quality Engineering. 

What is needed to succeed 

• 5 - 8 years’ experience as an MDR/Design Control specialist in a Medical Device company 
• Experience with creation and implementation of Medical Device development procedures and processes 
• In-depth understanding of regulations, standards, and guidelines within the medical device area e.g. 21CFR820.30, ISO13485, ISO14971, EU MDR/IVDR 
• Experience with participation in inspections/audits 
• Experience in training, facilitation and coaching of users of the procedures 
• Preferably hands-on Design Control experience including creation of records from idea generation to regulatory approval  
• Preferably experience with cross-functional process improvement projects 
• Good interpersonal skills to collaborate with stakeholders across organization and cultures  
• As a person you are structured, self-motivated, and detail-oriented and have a good sense of humor 
• Relevant educational background at minimum Master’s degree level 
• Fluent in oral and written English  

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. By joining us you will get the opportunity to work in the headquarter of an international company with an informal working environment. Your contributions and efforts will make a real difference for patients and health care professionals around the world.  

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 interested in the position, then please apply as soon as possible and no later than 15th June as we aim to have interviews concluded in June. 

If you have any questions about the position, you can contact Lotte W Trangbæk, Manager, Innovation Processes, Global Innovation, telephone +45 2130 5467.  

Your application will be treated with confidentiality. 

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