IT Compliance & Validation Specialist

Would you like to be a part of a fast-growing medical device company? Are you familiar with working with regulatory guidelines and corporate governance best practices? Then Ambu may be the next career move for you… 

Ambu is an international and inspiring company with ambitious growth targets. We develop, produce and sell medical devices and we are experiencing massive success. To ensure continued success, we are looking for an IT Compliance & Validation Specialist to support IT projects and line of business to ensure that our company adheres to legal and regulatory standards, authority requirements and internal policies and standards. 

In this position, you will be working closely together with the existing IT Compliance Manager and CISO where you will play an active role in getting Ambu secure, resilient, compliant and balancing risks with the many opportunities we have as a company. You will report to the Chief Information Security Officer. 

Your responsibilities 
You will be responsible for supporting IT and Business with IT and Security compliance and assurance activities during IT project and IT application operation lifecycle phases. Simultaneously you will constantly monitor our control effectiveness, make sure to deal with non-conformities in our IT landscape and in our business processes. Creating improvement plans, functioning as a subject matter expert and being a skilled advisor is a crucial part of this position. 

The primary responsibilities will be to: 

• Develop and oversee control systems to prevent or deal with non-conformities of regulatory, legal, security requirements and our internal policies 
• Assess and advise business and IT projects to identify possible compliance and security risks 
• Prepare and head/front internal and external audits and assurance activities 
• Support continuous improvement of the IT Quality Management System and work closely together with the IT QA functions and the IT compliance managers. 
• Propose and implement improvements related to IT compliance / security and bring the different frameworks together to make it easier for line of business to implement them and close the gaps. 
• Write and monitor the Deviation (CAPA) and follow up non-conformities 
• Support validation / qualification activities for computerized systems and drive periodic evaluation reports for computerized systems 
• Function as compliance subject matter expert to other department representatives, customers, and regulatory representatives 
• Cultivate integrated working relationships with employees and other departments to maintain and foster quality standards 
• Contribute to the IT department's activities to ensure continuity of operations. 
• Know, understand, and comply with the company's standard operation procedures and policies 

Your key competencies 
You have proven experience within IT compliance. It's an advantage if you have experience in Information security frameworks and policies in a regulated industry. Furthermore, you have an excellent understanding of reporting procedures and document management, along with a technical understanding of how IT systems and infrastructure are built and functioning. 

As a person you are methodical and diligent with good planning abilities and capable of maneuvering in a multi-sourcing environment. You have an analytical mind and can “see” the complexities of procedures and regulations. Lastly, you have excellent communication and collaboration skills and can provide internal training. 

As Ambu is a global company and our corporate language is English, you must be fluent in English, both written and verbally. 

Ambu – a visionary and international workplace where your efforts make a difference 
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. By joining us, you will get the opportunity to work in an international head office with an informal and cross-functional working environment. 

We offer a wide range of professional, social, and financial employee benefits along with exciting job challenges and career opportunities contributing to your job satisfaction. 

When to apply 
If you are ready to apply for the position, please apply as soon as possible. We will invite candidates for interviews on a continuous basis so no need to hesitate. This job ad will be online until February 23rd, 2022, but once we have found the right candidate, this ad will no longer be online. 

You can get additional information about the job and about Ambu by contacting Dennis Persson, CISO, at +45 2068 2998. 

Your application will be treated confidentially. 

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.

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