Randstad Professional
Post-Market Surveillance & Vigilance Specialist (IVD) (m/w/d)
Wiesbaden, Hessen, Germany
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- Role family
- Healthcare
- Seniority
- Mid level
- Country
- DE
- Work mode
- On-site / unstated
- First seen by hirly
- 26 Sept 2026
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the posting
- 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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