Medical Affairs Manager(m/w/x)

Beschreibung

You will ensure medical devices meet all safety standards by managing clinical evaluations and regulatory documentation. Your work keeps the products compliant and audit-ready.

Anforderungen

• •Degree in life/natural science or equivalent
• •Experience in medical device industry
• •Understanding of Medical Affairs processes
• •Expert knowledge in medical writing
• •Creation of Clinical Evaluation Plans
• •Strong attention to detail
• •Knowledge of regulatory requirements
• •Knowledge of Minimally Invasive Surgery
• •Knowledge in Clinical investigation
• •Fluent English and German skills
• •Open and competent stakeholder attitude
• •IT affinity and MS Office proficiency
• •Familiarity with AI tools
• •Willingness to travel on demand
• •Valid passport for international travel
• •Mobility for standard office work

Aufgaben

• •Maintain product compliance with regulatory guidelines
• •Ensure medical device conformity with safety requirements
• •Prepare and update PMS and PSUR documentation
• •Manage PMCF plans and reports
• •Develop clinical evaluation plans and reports
• •Maintain audit-ready documentation at all times
• •Support risk and change management processes
• •Handle nonconformance and corrective actions
• •Conduct scientific literature and vigilance searches
• •Evaluate data according to MDR and MEDDEV standards
• •Plan studies for CE-registrations and PMCF
• •Collaborate with R&D and product management teams
• •Coordinate with external service providers
• •Conduct annual PMCF surveys in hospitals
• •Attend conferences to track clinical innovations
• •Follow quality and occupational safety regulations
• •Implement environmental management instructions

Tools & Technologien