Post-Market Surveillance & Vigilance Specialist (IVD) (m/w/d)

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 , 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