Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $20 billion and 67,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands – Life Technologies, Thermo Scientific, Fisher Scientific and Unity Lab Services – offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com
Thermo Fisher Scientific Baltics, UAB creates, manufactures and distributes molecular biology products for life science research and diagnostics. Products are exported to more than 80 countries.
Thermo Fisher Scientific Baltics, UAB successfully expands its activities and invites to a friendly and more than 800 employees team:
Specialist, Regulatory Affairs
The Regulatory Specialist will join the Regulatory Affairs, Clinical and Compliance team based in Vilnius, Lithuania. He/She will be responsible for managing In-Vitro Diagnostic (IVD) and/or Medical Device regulatory submissions and regulatory compliance activities in line with corporate and divisional objectives.
- Compile, review and maintain documentation required for IVD products registration and regulatory support in EU. If required, align document authoring/preparation with other departments;
- Review and approve IVD products labeling and marketing information, labels, text, instructions for use, and assure that the labeling is in compliance with the applicable laws, regulations and registration documents. In cooperation with other functions ensure that labeling of the company IVD and other products used for pharmaceutical applications is in compliance with EU regulations;(atlieka ligavimo, ilgalaikės inkubacijos testus).
- Participate in new IVD products development process, contribute to solving technical and regulatory questions, collect from different departments documents, required for IVD products technical files creation; if needed prepare or coordinate preparation of required IVD technical files;
- Support post-market surveillance and vigilance activities;
- Immediately report to Direct Manager all non-standard situations related with direct functions;
- Prepare analysis of the activities related with direct functions; provide suggestions for improvement opportunities both in personal work assignments and in department processes;
- Participate in internal or external audits performed by NBs/competent authorities or by other parties, related with IVD products registration;
- University degree in the Life-Sciences;
- English language;
- Computer literacy (MS Office).
- Knowledge and work experience, skills:Knowledge of laws and regulations of the Republic of Lithuania, EU, US and other markets on registration of Medical Devices, IVD products and/or medicinal products;
- Experience in the field of registrations of medical devices, IVD products and/or medicinal products or work experience in the medical device or pharmaceutical manufacturing company for over 3 years;
- Knowledge of standards for Quality Management Systems and requirements of current Good Manufacturing Practices;
- Skills of data collection and processing;
- Abilities to plan, organize and coordinate working process;
- Knowledge of documents management and archiving principles;
- Developed communication skills, ability to express ideas in a consistent and understandable manner, both written and orally (in Lithuanian and English);
- Good skills working with computers and office hardware;
- Experience working with information databases and electronic documents content management systems;
- Thoroughness, responsibility, attentiveness, dutifulness.
- Anglų kalba.
- Kompiuterinis raštingumas.
- Analizės metodų išmanymas ir analizės atlikimo įgūdžiai.
- Kokybės vadybos sistemos standartų reikalavimų žinojimas.
- English language;
- The innovative environment of the rapidly growing international company.
- An exciting opportunity to be part of a dynamic global organization and work with experienced professionals.
- High performing, driven and supportive working culture and outstanding development possibilities to increase your potential.
We are looking forward for your CV. Jon offer ID - 75749BR.