Beschreibung

As a Regulatory Affairs Specialist, you will manage regulatory submissions and ensure compliance by recommending improvements and strategies. Your role involves coordinating with internal teams and staying updated on regulations while supporting decision-making processes.

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

• •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
• •Recommend improvements to enhance system and process effectiveness
• •Communicate regularly with internal stakeholders to share updates and gather input
• •Guide entry-level professionals or support staff as needed

Benefits