Junior software 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.

Define and Execute Strategy: Establish and drive the global regulatory strategy for the Pharmaceutical Business Unit, ensuring direct alignment with our commercial objectives and Testo's 2030 vision....

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...

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...

• Collect data and prepare progress reports, KPIs, and metrics for regional and global reporting, including monthly reports, management reviews, and quarterly quality reports.
• Support ad hoc global quality reporting by gathering data and providing contextual insights to regional QA Senior Management.

• 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

• Serve as the Regional Business Process Owner for GMP/GDP Quality Assurance processes related to Complaint Management and Recall within the EUCAN region.
• Lead the regional standardization and harmonization of Complaint Management and Recall processes, ensuring alignment with GMP and GDP requirements.

• Serve as the Regional Business Process Owner for GMP/GDP Quality Assurance processes related to Deviation, CAPA, and OOx within the EUCAN region.
• Drive the standardization and harmonization of these processes at a regional level, ensuring alignment with both GMP and GDP requirements.

• 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

• 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.