Regulatory Affairs Professional Medical Devices(m/w/x)

Beschreibung

In this role, you will be at the forefront of regulatory compliance, preparing essential documents for clinical evaluations and post-market surveillance. Your day-to-day responsibilities will involve advising stakeholders on regulatory changes, conducting risk assessments, and ensuring that all processes meet the latest standards.

Anforderungen

• •Master’s degree in natural sciences, medical technology, biotechnology, or comparable field
• •First experience in Regulatory Affairs for Medical Devices and/or In Vitro Diagnostics
• •Experience in scientific writing, especially Post-Market Surveillance and clinical documents
• •Knowledge in interpretation of regulations and cooperation with regulatory authorities
• •Excellent organizational skills and ability to set priorities
• •Excellent analytical skills and knowledge of scientific principles
• •Assertiveness, resilience, good sense for counterpart, clear communication, and people management skills
• •Fluent German and English skills, both spoken and written

Aufgaben

• •Prepare clinical and performance data documents
• •Create post-market surveillance documents for medical devices and IVDs
• •Support the Regulatory Affairs Specialist with technical documentation in the EU
• •Develop schedules and ensure compliance
• •Monitor market developments and conduct research
• •Evaluate research findings
• •Perform risk assessments and initiate corrective actions for incidents
• •Analyze new regulatory requirements and implement necessary activities
• •Advise internal stakeholders on regulatory changes and standards
• •Communicate with authorities and submit regulatory documents
• •Assess the regulatory impact of product changes
• •Develop and implement new processes to meet regulatory requirements
• •Write procedures and work instructions
• •Monitor compliance with regulatory procedures and workflows

Benefits