About Abbott
Abbott is a global health care leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
In Germany, Abbott has more than 4 ,000 employees working in manufacturing, research and development, logistics, manufacturing, sales and marketing. They are located at Abbott`s German headquarters in Wiesbaden and its sites in Hanover, Neustadt am Rübenberge, Wetzlar, Eschborn, Cologne, Jena and Hamburg.
W orking at Abbott
At Abbott, you can do work that matters and help people to live a healthier and full life, grow your career, and learn, be your true self. You will have access to:
* Career development with an international company where you can grow the career you dream of
* An attractive benefits package ( e.g. attractive Abbott Pension Plan, a company bike, employee stock purchase program)
* A company r ecognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
* A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
* A challenging position in a fast-growing crisis independent industry
* To become part of a dynamic, highly educated, highly skilled, and motivated team
* Flat hierarchies, open appreciative mentality, and efficient, constructive lines of communication
* Multi-national environment, where we foster the development of our talents within the enterprise
The Opportunity
This position works out of our Wiesbaden-Delkenheim Abbott GmbH location
We are seeking for a Vigilance Specialist for IVDs & Medical Devices (m/f/d)
Your Tasks
* Vigilance and post-market surveillance activities in compliance with international regulatory requirements for in-vitro diagnostics and medical devices specifically for Core Diagnostics and Molecular Diagnostics products from Abbott, focusing on the European Economic Area, Switzerland, and Great Britain.
* Incident report review and submission to relevant authorities and notified bodies
* Preparation of Field Safety Corrective Action reports and Trends reports based on manufacturer-provided information and reporting to authorities
* Handling of authority inquiries within specified deadlines by compiling and consolidating information from various departments.
* Monitoring current vigilance legislation, especially within the European Economic Area.
* Participation in or leading projects related to vigilance/post-market surveillance processes.
Your Profile
* Strong academic background in a scientific discipline (e.g., life sciences, medicine, pharmacy); advanced degrees (Diploma, PhD) are advantageous.
* Experience in In-Vitro Diagnostics, Medical Devices, and/or the Pharmaceutical industry.
* Additional expertise in pharmacovigilance, regulatory affairs, or vigilance within medical technology industry is a plus
* Proven ability to work in international environments or on global projects; international work experience is a plus.
* Proficiency in English (fluent) and German (very good); additional European languages are beneficial.
* Competent in using PC-based applications and digital tools.
* Excellent communication and negotiation skills.
* Cultural sensitivity and a collaborative team-oriented mindset.
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
We ask for your understanding that we only consider online applications via our online application portal. Applications by email or post cannot be processed. Original documents will not be returned.
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