Design Control Specialist – Copenhagen, Denmark

Recruitment closed. This is an archived vacancy. The role description remains available for reference. LiNA Medical is looking for a Design Control Specialist with an engineering or similarly relevant background.

You have solid experience with working in the crossing between RA – R&D – QA and are comfortable ensuring compliance in the teams’ projects where the focus will be on Design Control. The position will also encompass related areas of responsibility such as supporting work with CAPA, implementing new standards, and participating actively in audits.

Responsibilities

Together with the Project Manager and the rest of the team you will be responsible for ensuring the quality of the documentation in the project.

The main focus is compliance with external requirements, ensuring that the projects are continuously in compliance with the regulatory equirements You will be responsible for driving your own job tasks, and together with the Project Manager you will further be responsible for ensuring that the rest of the team are aligned with the creation of the technical file.

Together with the entire R&D organization you will be responsible for ensuring that LiNA Medical’s procedures for development are continuously up-to-date and effective. This requires insight into the use of relevant regulatory standards within MedTech as well as solid experience with Design Control1 …