Position
For our client – an international leader in the In‑Vitro Diagnostics (IVD) and medical device industry located in Wiesbaden – we are looking 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 on regulatory compliance for IVD devices, molecular diagnostics, antibody testing, and medical software solutions.
Responsibilities
- Vigilance & PMS: Conduct vigilance and post-market surveillance activities in accordance with international regulatory requirements for medical devices and IVDs, with a focus on the EEA, Switzerland, and the UK.
- Incident Reporting: Review and report incidents to competent authorities and Notified Bodies.
- FSCA & Trend Reporting: Prepare trend reports and documentation related to Field Safety Corrective Actions (FSCAs) based on manufacturer-provided information and submit them to authorities.
- Authority Inquiries: Respond to regulatory authority inquiries within established timelines by consolidating relevant information from various departments.
- Regulatory Monitoring: Monitor and assess current vigilance regulations, particularly within Europe.
- Project Support: Participate in and support projects related to vigilance and post-market surveillance in an international setting.
Qualifications
- Education: Degree or professional qualification in a scientific, medical, or pharmaceutical field (Bachelor, Master, or PhD).
- Industry Experience: Professional experience in the in vitro diagnostics (IVD), medical device, or pharmaceutical industry.
- Functional Background: Experience in vigilance, post-market surveillance (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.
Benefits
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
#J-18808-Ljbffr
Post-Market Surveillance & Vigilance Specialist (IVD) (m/w/d) in Wiesbaden Arbeitgeber: Randstad Professional
Randstad professional solutions bietet Ihnen als Sachbearbeiter im Einkauf und in der Produktionsplanung ein attraktives Arbeitsumfeld, das Vielfalt und Chancengleichheit fördert. Genießen Sie ein wettbewerbsfähiges Gehaltspaket, inklusive Weihnachts- und Urlaubsgeld sowie einen Zuschuss zur betrieblichen Altersvorsorge nach der Probezeit. Darüber hinaus profitieren Sie von bis zu 30 Tagen Urlaub pro Jahr und umfangreichen Weiterbildungsmöglichkeiten, während Sie die Flexibilität haben, überwiegend im Homeoffice zu arbeiten.
