Randstad is one of the world's leading talent companies with the ambition to be the world's most equitable and specialized talent company. 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 path with equitable opportunities.
Randstad Professional is one of Randstad's four specializations and focuses on the placement of specialists and managers in the future-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 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.
- 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.
- 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.
- 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
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Post-Market Surveillance & Vigilance Specialist (IVD) (m/w/d) in Wiesbaden Arbeitgeber: Randstad Deutschland
Unser Unternehmen in Emsdetten bietet Ihnen als Lagerarbeiter (m/w/d) eine hervorragende Arbeitsumgebung mit leistungsgerechter Vergütung und attraktiven Sozialleistungen, einschließlich Urlaubs- und Weihnachtsgeld. Wir fördern eine positive Teamkultur und bieten Ihnen die Möglichkeit, sich beruflich weiterzuentwickeln, während Sie von Sonderkonditionen bei verschiedenen Anbietern profitieren. Bei uns stehen Chancengleichheit und ein respektvolles Miteinander im Vordergrund, was uns zu einem ausgezeichneten Arbeitgeber macht.
