2022-07-29 11:26:48

Regulatory Affairs Specialist

CVMarket.lt klientas
2100 - 3200 €/mėn. Prieš mokesčius

Darbo aprašymas

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 and/or Ancillary/Raw/Starting Materials used in pharmaceutical applications 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 and/or Ancillary/Raw/Starting Materials used in pharmaceutical applications registration and regulatory support in EU, US and other countries globally;
  • Review and approve products labelling and marketing information, labels, text, 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 from different departments documents, required for creation of products technical documentation;
  • Create and keep up to date technical documentation - Technical Files and/or Master Files;
  • Provide regulatory support and expertise to project teams and different functions/ departments.
  • Support products post-market surveillance and vigilance activities;
  • Participate in internal or external audits performed by Notified Bodies/ Competent Authorities or by other parties;
  • 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;

Reikalavimai

  • 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 medicinal products and/or medical devices, IVD 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;
  • 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;

Įmonė siūlo

  • 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.
  • Monthly salary 2100- 3200 Eur (Brutto) and additional benefits package.