Junior python developer állás, munka

• Gyógyszerek hazai és nemzetközi törzskönyvezési, módosítási és megújítási eljárásainak előkészítése és lebonyolítása (OGYÉI, MRP/DCP).
• Törzskönyvi dokumentációk (CTD modulok) összeállítása, ellenőrzése, hiánypótlások és hatósági válaszok előkészítése.

This role reports to the FMC Corporation’s Global Regulatory Sciences group and is part of the Global R&D organization....

• Drive regulatory strategy for new product launches, ensuring proactive and effective planning aligned with global requirements
• Lead a team of regulatory experts in External Devices & Software within Regulatory Affairs

• You ensure that each batch is manufactured and tested in accordance with legal regulations
• You approve or reject bulk and finished products and sign the corresponding test protocols
• You approve specifications, sampling instructions, and testing instructions and ensure compliance with them

• Performing post-market surveillance and vigilance activities in accordance with internal procedures and applicable regulations
• Coordination of recalls and field actions as well as establishing and maintaining quality system related workflows, processes and procedures

Definition and implementation of the clinical evaluation strategy for complex and challenging development projects focused on innovative microsurgical applications in the area of intra-operative visualization and digital imaging in neurosurgery...