Kitchen manager in állások, munkák törzskönyvezés kategóriában

• 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

• 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

Execution of consulting projects with a focus on developing market access and dossier strategies, including preparation of corresponding workshops, and participation in oral hearings with relevant authorities...

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

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

• Drive and complete reimbursement applications for the Vibrant product portfolio
• Build and check health economic models that clearly demonstrate product value by using appropriate software tools

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

• 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.

• 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.

• Accountability to lead teams within overall CMC development project(s)
• Drive strategies and activity within the team to support overall development plan.
• Establish good working relationships with internal and external stakeholders

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