Törzskönyvezés állások, munkák

Állatgyógyászati termékek regisztrációs dossziéjának II. részének (Part II) szerzői és szakmai elkészítése, strukturált átírása és naprakésszé tétele a hatályos EU-s és hazai előírások szerint....

• Acquiring and maintaining marketing authorizations.
• Creating the necessary submissions for authorizations and tracking them from the first documentation until authority decision.
• Monitoring relevant legal changes and verifying the accuracy of packaging materials and patient information leaflets.

• Gyógyszer törzskönyvezéshez kötődő feladatok, törzskönyvi dokumentációk, beadványok összeállítása angol nyelven
• A gyógyszerek életciklusa alatt a változások kezelése, módosítások támogató dokumentációjának összeállítása angol nyelven
• Eljárások koordinálása

Regulatory Affairs ManagerMyLife Diabetes Care AG is a new, independent medtech company specialising in the treatment of diabetes using advanced insulin pump systems. To strengthen our Quality Management department, we are looking for a very experienced person on a high seniority level for our...

Risk-Manager% (f/m/d)True to the vision "We drive innovation to improve people's lives", the Hamilton companies have been providing solutions for the health sector sinceWe are an innovative pioneer in the field of ventilators.Hamilton Medical is a leading manufacturer of intelligent ventilators....

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities

Technical Support Manager API (f/m/d)%The IMCD Group is a global market leader in the sales, marketing and distribution of specialty chemicals and ingredients. With a global network of industry experts, IMCD offers its suppliers and customers in the EMEA, Americas and Asia Pacific regions...

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

• 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

Senior Patent CounselAt Abbott, we’re driven by a mission: to help people live healthier, fuller lives. With a presence in over 160 countries and a team of 114,000 diverse colleagues, we’re committed to advancing innovation across diagnostics, medical devices, nutrition, and pharmaceuticals.We’re...

Create and/or hold scientific presentations, lectures, training courses, speaker decks, FAQ documents etc. with targeted content for the respective stakeholders...

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...