Regulatory Affairs Engineer
1 day ago
We are seeking a Regulatory Affairs Engineer to join our team at CIM A/S. In this role, you will be responsible for ensuring the compliance of our software systems with pharmaceutical regulations.
You will work closely with project managers, software developers, and customers' validation teams to develop solutions that meet regulatory demands. Your responsibilities will include participating in the design phase, contributing to the creation of Software & Hardware Design Specifications and Requirement Traceability Matrices.
Main responsibilities:
- Participating in project execution and ensuring that our solutions meet regulatory demands.
- Contributing to the design phase, including developing Software & Hardware Design Specifications and Requirement Traceability Matrices.
- Supporting the organization in their day-to-day tasks, including updating validation documentation and QMS processes.
The ideal candidate will have a degree in a technical field, experience with the validation process, and knowledge of technical deliveries for projects like URS, SDS, FS, RTM, and Test Plans.
This is an excellent opportunity to join a talented team working on production software solutions for globally leading pharmaceutical companies. We offer flexible working arrangements, allowing you to adapt your schedule to fit your lifestyle.
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