Lead Regulatory Affairs Specialist(m/w/x)

Beschreibung

In this pivotal role, you will lead the regulatory lifecycle of medical devices, ensuring every step from development to market placement meets strict global standards through expert coordination.

Anforderungen

• •Long-term functional professional experience
• •Studies in natural sciences, engineering, or medicine
• •Manager Regulatory Affairs for Medical Devices training
• •English Level CEFR C1
• •German Level CEFR B2
• •Quality-oriented, reliable, and dependable nature
• •High level of self-motivation
• •Teamwork skills
• •Independence and self-reliance
• •Excellent communication skills
• •Well-structured and systematic working style
• •Willingness to travel up to 10%

Aufgaben

• •Ensure medical devices meet all regulatory requirements
• •Perform timely regulatory submissions for market placement
• •Anticipate and plan necessary regulatory tasks
• •Coordinate relevant cross-functional teams
• •Compile approval documents and legalizations
• •Prepare documentation for notified bodies and authorities
• •Control technical documentation for conformity assessments
• •Prepare and release declarations of conformity
• •Support development of design control processes
• •Implement risk management and clinical evaluations
• •Review and release design validation protocols
• •Evaluate change orders for regulatory relevance
• •Process general regulatory affairs inquiries
• •Interpret standard requirements for electrical safety and cybersecurity
• •Act as interface between customers and authorities
• •Support audits in cooperation with the QMR
• •Process safety-related complaints with Medical Affairs
• •Monitor measures to maintain the quality management system
• •Comply with occupational safety and environmental regulations

Benefits