svg
36
svgĮsiminti

Regulatory Affairs Specialist

svg
36

The Regulatory Affairs Specialist will join the Regulatory Affairs, Clinical and Compliance team based in Vilnius, Lithuania. They will be responsible for managing (IVD) Medical Devices and Instruments regulatory submissions and regulatory compliance activities in line with corporate and divisional objectives.


Tasks and Functions:
  • Compile, review and maintain documentation required for Medical Devices and Instruments regulatory support in EU, US and globally.
  • Review and approve products labelling and marketing information, texts, instructions for use, and assure that the labelling is in compliance with the applicable laws, regulations and registration documents.
  • Participate in new products development process, contribute to solving technical and regulatory questions, collect documents from different departments, required for creation of products' technical documentation.
  • Create and keep up to date technical documentation, incl. Technical Files.
  • Provide regulatory support and expertise to project teams and different functions/ departments.
  • Support products post-market surveillance and vigilance activities.
  • Participate in audits performed by Notified Bodies/ Competent Authorities or by other parties.
  • Prepare analysis of the activities related with direct functions; provide suggestions for improvement opportunities.

Requirements:
  • University degree in the Life-Sciences.
  • 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 or IVD and/or medicinal products or work experience in the medical device or pharmaceutical manufacturing company.
  • Knowledge of standards for Quality Management Systems and requirements of current Good Manufacturing Practices.
  • 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).
  • Experience in working with information databases and electronic documents content management systems.

The Company Offers:
  • Meaningful, mission-based work;
  • 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.
  • Professional career opportunities;
  • Work in an ambitious team;
  • Monthly salary 2000 - 3500 Eur (Brutto) and additional benefits package.

Contacts

Contact person:

Lina Eidikytė

E-mail:

 with subject "Regulatory Affairs Specialist (185076BR)"