Team Leader Post Market Surveillance(m/w/x)

Beschreibung

In this role, you will lead a team of Post Market Surveillance experts, ensuring compliance with regulatory standards while influencing product lifecycle decisions. Your day-to-day responsibilities will involve overseeing documentation and assessing risks to enhance product management services.

Anforderungen

• •Higher education degree in healthcare, life sciences, or business administration
• •Profound professional experience in regulatory compliance for MDR and IVDR
• •Strong understanding of risk management and vigilance reporting
• •Familiarity with quality management systems
• •Extensive experience in designing and implementing PMS processes across multiple markets
• •Proven experience in managing cross-functional projects
• •Ideally first experience of leading teams
• •High level of proactivity, flexibility, and teamwork orientation
• •Excellent written and verbal communication skills in English
• •German highly beneficial

Aufgaben

• •Lead and develop a team of Post Market Surveillance experts
• •Act as the main interface between PMS, Regulatory Affairs, Quality, and Product Management
• •Communicate PMS findings and recommendations to influence product lifecycle decisions
• •Define and maintain PMS processes to ensure regulatory compliance
• •Oversee timely completion of PMS documentation, including PMS, PMCF, PMPF, PSUR, and vigilance reports
• •Assess risks relevant to medical devices and in vitro diagnostics within PMS documents
• •Manage the budget for the PMS team

Benefits