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Thermo Fisher Scientific

Regulatory Affairs Specialist

2400-2900 eur/mon. Gross
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Net per month
Vilnius - Thermo Fisher Scientific

Job description

  • Compile, review and maintain documentation required for IVD Medical Devices and/or Ancillary/Raw Materials used in pharmaceutical applications registration and regulatory support in EU, US and other countries globally.
  • Review and approve product 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.
  • Participate in new IVD products and/or Ancillary/Raw Materials used in pharmaceutical applications development process, contribute to solving technical and regulatory questions, collect from different departments documents, required for the creation of products technical documentation.
  • Create and keep up to date Medical Device, Technical Files and/or Drug Master Files.
  • Provide regulatory support and expertise to project teams and different functions/ departments.
  • Support Medical Device post-market surveillance and vigilance activities.
  • Participate in internal or external audits performed by NBs/competent authorities or by other parties.
  • Immediately report to Direct Manager all non-standard situations related to direct functions.
  • Prepare analysis of the activities related to direct functions; provide suggestions for improvement opportunities both in personal work assignments and in department processes.

Requirements

  • University degree in the Life-Sciences.
  • English language.
  • Computer literacy (MS Office).
  • Knowledge of laws and regulations of the Republic of Lithuania, EU, US and other markets on registration of Medical Devices, IVD and/or medicinal products.
  • Experience in the field of registrations of medical devices, IVD 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 the 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 in working with information databases and electronic documents content management systems.
  • Thoroughness, responsibility, attentiveness, dutifulness.

We offer

  • The innovative environment of the rapidly growing international company.
  • High performing, driven and supportive working culture and outstanding development possibilities to increase your potential.
  • An exciting opportunity to be part of a dynamic global organization and work with experienced professionals.

Salary

2400-2900 eur/mon. gross

Thermo Fisher Scientific

„Thermo Fisher Scientific“ – didžiausia pasaulio kompanija, siūlanti produktus ir paslaugas mokslui. Mūsų misija – padėti klientams kurti sveikesnį, švaresnį ir saugesnį pasaulį.

Kompanijos padalinys Vilniuje – UAB „Thermo Fisher Scientific Baltics“ kuria ir gamina produktus gyvybės mokslų tyrimams ir diagnostikai. Produktai yra plačiai naudojami visame pasaulyje tiriant genų sandarą, raišką ir įvairovę, kuriant naujus diagnostikos metodus.

Esame vertinamas kaip geidžiamas darbdavys: 2020 m. Lietuvoje mums įteiktas Metų darbdavio apdovanojimas, 2019 m. - pripažinti Lietuvos TOP darbdaviu gamybos sektoriuje.
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information about Thermo Fisher Scientific
2116 €
Avg. salary gross
(51% higher than LT average)
1292
Number of employees
>100 mln. €
Revenue 2019 y.
Distribution of employees by salary (before taxes):
25% earn up to 1409 €
25% earn 1409-1772 €
25% earn 1772-2472 €
25% earn more than 2472 €