Jogi manager állások, munkák törzskönyvezés kategóriában

Serve as the labeling lead for all global labeling matters, ensuring regulatory‑compliant, current, and competitive core labeling documents (CDS, BPL, BSS)....

Define and lead the global Clinical Affairs strategy for Brainlab's global surgery portfolio, ensuring alignment with product, regulatory and commercial objectives / teams...

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...

• Serve as the primary regulatory contact for Swissmedic for assigned products
• Prepare and manage regulatory submissions for new marketing authorisations and lifecycle changes
• Develop and implement regulatory strategies for Switzerland in coordination with international teams

• Risk Identification & Assessment - Analyze risks related to product development, manufacturing, post market, useability, biocompatibility, cybersecurity, vigilance, compliance, etc..
• Implementation of Risk Controls - Develop strategies to minimize risks and improve processes.

• Drive global CMC strategies for clinical trial applications, new product licenses, and post-approval changes.
• Assess CMC, facility/equipment, and plasma-related changes and manage regulatory submissions in coordination with regional teams.

• Identification of patenting opportunities, drafting of patent applications and development of suitable filing strategies
• Handling of all stages of patent prosecution, including requesting SPCs/PTEs where applicable
• Supporting the Patent Conflicts Team as needed