Responsible for all RA deliverable linked to the registration and certification of the medical devices in Russia, collecting the registration dossier for CIS region, maintenance of registrations in Russia and other countries of the CIS region as assigned by his/her direct manage.
Supporting development and execution of regulatory strategies for assigned projects for Russia. This will include the creation of submission dossier compilation of documentation and managing of timelines.
Monitoring submission timelines and timely responses to requests competent authorities or other partners involved in product registration. It also includes constant support for the development/ improvement of RA processes for efficient product registration in Russia.
Support change projects by providing RA impact assessments and support defining the necessary activities on local level.
Monitoring of the medical device legislation in Russia and define and maintain an overview of the regulatory requirements and changes in the areas.
Support in training other departments to ensure continued compliance and timely market release in Russia.
Support in development and execution of regulatory strategies for assigned projects for product registration and maintenance in the CIS region.
Accountable for regulatory compliance
Assessment and regulatory implementation of change requests
Review and approval of product related labeling
Monitoring legislative environment in relevant markets
Training internally on relevant procedures and requirements
Support audits by competent authorities as well as internal audits
Salary - negotiable
Technical or scientific background, university degree is an advantage
Working knowledge of medical device legislation in Russia and corresponding guidelines
Additional knowledge of legislation in other countries of the CIS region is of advantage
Understanding of the European CE marking process
Good knowledge of quality system requirements such as ISO 13485
Additional knowledge of software development requirements (IEC 62304 and ICE 62366) as well as standards for electrical products such as IEC 60601 are an advantage.
Fluent in Russian and English (writing, reading and speaking), further languages are an advantage
Highly organized and able to work under deadlines
Strong interpersonal skills and proactive working attitude in a international matrix organisation
Excellent writing and communication skills
Minimum 3 experience in regulatory affairs within the Medical Device Industry in Russia
Understanding of EU medical Device regulations
Временная работа, полный рабочий день, у работодателя