Beschreibung

In this role, you will ensure that medical devices comply with regulatory standards while managing documentation and approvals. Your day-to-day responsibilities will involve collaborating with cross-functional teams, supporting audits, and addressing safety-related incidents.

Anforderungen

• •Completed studies in natural sciences, engineering, medical, or comparable field
• •Advanced training 'Manager Regulatory Affairs for Medical Devices'
• •English Level CEFR C1, German Level CEFR B2
• •Quality-oriented, reliable, and dependable
• •Self-motivated
• •Team player
• •Independent and self-reliant
• •Excellent communication skills
• •Well-structured and systematic way of working

Aufgaben

• •Ensure medical devices meet regulatory requirements
• •Compile approval-relevant documents, including free sales certificates
• •Prepare documentation for evaluations by notified bodies and authorities
• •Control technical documentation for conformity assessment procedures
• •Assess compliance with essential requirements
• •Prepare and release declarations of conformity
• •Support development and updating of design control processes
• •Participate in risk management, clinical evaluation, and usability file implementation
• •Review and release approval-relevant documents in design control
• •Evaluate change orders for regulatory relevance
• •Process RA-related general inquiries
• •Interpret standard requirements for clinical evaluation and safety
• •Act as an interface between RA departments and external bodies
• •Support audits in coordination with the Quality Management Representative
• •Process safety-related complaints with the Medical Affairs team
• •Monitor measures to maintain the Quality Management System
• •Ensure compliance with quality, safety, and environmental regulations
• •Implement instructions from quality and safety representatives