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

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