Beschreibung

In this role, you will enhance regulatory processes and systems while collaborating with internal teams. Your day-to-day responsibilities will involve preparing submissions, guiding junior staff, and ensuring compliance with evolving regulations.

Anforderungen

• •Bachelor's degree in Life Sciences, Engineering, Chemistry, or related technical field
• •2-5 years of medical device regulatory experience tied to Swissmedic submissions and processes
• •Proficiency in German, English, and French
• •Experience in ISO 13485 Quality Management Systems and risk management (ISO 14971, EN 14971)
• •Experience with Swissmedic registration processes and technical documentation preparation

Aufgaben

• •Recommend improvements to systems and processes
• •Communicate regularly with internal stakeholders
• •Guide entry-level professionals and support staff
• •Coordinate and prepare document packages for regulatory submissions
• •Lead and compile materials for submissions, license renewals, and annual registrations
• •Recommend changes for labeling, manufacturing, marketing, and clinical protocols
• •Monitor and improve tracking and control systems
• •Stay updated on regulatory procedures and changes
• •Interact with regulatory agencies on defined matters
• •Suggest strategies for timely approvals of clinical trial applications

Benefits