Randstad is one of the world's leading talent companies with theambition to be the world's most equitable and specialized talentcompany. Through our "partner for talent" corporate strategy, we find,develop and connect specialized talents with companies - worldwide,locally and always at a high speed. We build high-quality, diverse,and agile teams, while individuals can enjoy a rewarding career pathwith equitable opportunities.Randstad Professional is one of Randstad's four specializationsand focuses on the placement of specialists and managers in thefuture-oriented sectors of IT, Engineering, Life Science and Office.For our client – an international leader in the In-Vitro Diagnostics(IVD) and medical device industry located in Wiesbaden – we arelooking for a Post-Market Surveillance & Vigilance Specialist (IVD)(m/f/d) on a freelance basis. Duration: until 30.10.2027, full-time(preferred), 1 day/week remote possible.In this role, you will support an international team focusing onregulatory compliance for IVD devices, molecular diagnostics, antibodytesting, and medical software solutions.- Vigilance & PMS: Conduct vigilance and post-market surveillanceactivities in accordance with international regulatory requirementsfor medical devices and IVDs, with a focus on the EEA, Switzerland,and the UK.- Incident Reporting: Review and report incidents to competentauthorities and Notified Bodies.- FSCA & Trend Reporting: Prepare trend reports and documentationrelated to Field Safety Corrective Actions (FSCAs) based onmanufacturer-provided information and submit them to authorities.- Authority Inquiries: Respond to regulatory authority inquirieswithin established timelines by consolidating relevant informationfrom various departments.- Regulatory Monitoring: Monitor and assess current vigilanceregulations, particularly within Europe.- Project Support: Participate in and support projects related tovigilance and post-market surveillance in an international setting. - Education: Degree or professional qualification in a scientific,medical, or pharmaceutical field (Bachelor, Master, or PhD).- Industry Experience: Professional experience in the in vitrodiagnostics (IVD), medical device, or pharmaceutical industry.- Functional Background: Experience in vigilance, post-marketsurveillance (PMS), or regulatory affairs.- Language Skills: Fluent English is mandatory (spoken, written,reporting). German language skills are a plus.- Tools: Proficiency in data processing tools (e.g., Excel, Power BI,Power Automate) is an advantage. - Attractive options for shortening your personal payment term - No more time-consuming invoicing- Fast, reliable payment of fees - Conclude project contracts by means of electronic signature