Regulatory Affairs Specialist
- 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.
- 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.
- 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.
with subject "Regulatory Affairs Specialist (185076BR)"