Are you passionate about compliance and IT? 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!
We are looking for an IT Compliance Manager to join our Information Security and IT Compliance team based in Ballerup. In this role, you will ensure that our company adheres to legal and regulatory standards, authority requirements, and internal policies and standards.
Key Responsibilities
Your main responsibilities will include:
- 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 related to IT compliance processes and work closely together with the IT QA functions in Global Quality Management departments.
- Propose and implement improvements related to IT compliance / security and bring the different frameworks together to facilitate implementation for the line of business, offering guidance and support throughout.
- Drive and monitor non-conformities and CAPAs pertaining to Global IT.
- Support validation / qualification activities for computerized systems (applications and infrastructure) and drive periodic evaluation reports for computerized systems.
- Act as a 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.
- Know, understand, and comply with the company's standard operation procedures and policies.
- Function as a compliance subject matter expert on test management.
- Contribute with compliance oversight in close collaboration with Global IT System Owners and business stakeholders.
Suggested candidate profile
Skills
Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:
- Have proven experience within IT compliance and test management processes and tools, with a curious, methodical, and diligent approach to your work.
- Have experience in Information security frameworks and requirements in a regulated industry, (e.g.,ISO13485, 21 CFR Part 11, GAMP5, Data Integrity and ISO 27001 for Information Security Management), and are capable of maneuvering in a multi-sourcing environment.
- 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. You possess good planning abilities and an analytical mind, able to understand the complexities of procedures and regulations.
- Have excellent communication and collaboration skills, able to provide internal training and cultivate integrated working relationships with employees and other departments.
- Are fluent in English, both written and verbally, and have experience working in a multicultural organization.
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 great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.
