Medical Writer/Regulatory Affairs

? Compiling CTD dossier of API for the European market and
also for Commonwealth of Independent States (CIS) ?
Compiling and updating Technical File and Risk Management
documentation for sterile, implantable class III medical devices
at the current state-of-the-art ? Collaborating and
communicating with the notified body in charge of the
assessment of conformity ? Assessing, evaluating, and
interpreting ASMF and other documents from suppliers to
characterize the API ? Maintaining contact with R&D, QC, QA,
and purchasing department, to identify priorities and gathering
data. ? Responsible for compiling medical device regulatory
submissions ? Respond to and resolve all regulatory related
inquiries

? Responsible for compiling medical device regulatory
submissions ? Preparation of documents produced for
participation in tenders ? Daily updating of the database with
product documents ? Operating in accordance with the
applicable procedures of the quality management system ?
Preparation and management of notification documents for
medical devices ? Periodic verification of the EC certificates
for the commercialized medical devices ? Registration of
product quality complaints ? Provides documentary support
during corrective and withdrawal actions respond to and resolve
all related regulatory inquiries

? Perform quality assurance efforts on multiple application
releases, and monitor and document testing activities. ?
Manage to test for application deployments and assign testing
activities to the team. ? Design, develop and maintain test
cases and strategies for cross-browser testing and multiple
user scenarios. ? Satisfy release deliverables, project testing
requirements, and other quality assurance responsibilities. ?
Collaborate with the team to understand product changes and
QA testing requirements to deal with issues/defects in a timely
manner. ? Establish a testing feedback loop with other
developers and team members. ? Create written
documentation and procedures for application testing and
compliance. ? Debug test environment, automate sprints and
develop testing scenarios