Junior python developer állások, munkák törzskönyvezés kategóriában

• 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.

Point of contact for Regulatory Affairs colleagues with focus on Latin America regarding product registrations, including guidance on responding to deficiency letters and regulatory authority inquiries...

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams

• 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

• Lead and support cross-functional projects in regulatory affairs and quality management.
• Identify, interpret, and implement regulatory requirements across global markets, with a strong focus on international registrations outside the U.S. and EU.

Lead International Registration Projects: Spearhead cross-department initiatives for non-active medical devices in ophthalmology, spanning risk classes I to III. Analyze approval requirements and strategize implementation options, independently deriving registration strategies....

• 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...