Position Summary
Develops and applies basic knowledge and understanding of the RA frameworks, legislative requirements, processes and procedures in the EMEA distribution organization.
Key Activities & Accountabilities
Regular maintenance of corporate and local trackers, registers and databases;
Invoice processing - reconciliation, payment and register maintenance;
Document processing - scanning, archiving, and register maintenance;
Medical device new registration and registration certificates updates.
Creates and maintains supplemental labelling for medical devices, ensuring compliance with regulatory requirements.
Executes RA activities in line with defined procedures and processes.
Collects, organizes and maintains files on local, regional, and global RAQA intelligence.
Support the development and deployment of new systems and procedures within the RAQA organization.
Supports continuous improvement activities across RAQA.
Performs based on established targets, KPIs and objectives for RAQA.
Provides support to EMEA / Country RAQA teams as appropriate.
Education
BSc degree in relevant field.
Experience
0 years’ experience.
Knowledge/Competencies
Time management skills, writing, coordination, and execution of basic RA items.
Coordinate and support technical and scientific RA activities.
Under supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility.
Some evaluation, originality or ingenuity is required.
Clearly conveys information to peers, supervisors, and other stakeholders across the EMEA organization, Design Divisions and third-party distributors.
Assists in the preparation for meetings with regulatory agencies, internal and external audits and other stakeholders.
Assists in the preparation of briefings and other information documents.
Communicates information on RA requirements to other departments and business units.
Composes routine communications with regulators and other key stakeholders.
Creates clarity and direction amid complexity and develops solutions for self, colleagues, and the organization.
Seeks out diverse ideas, opinions, and insights, and applies them in the workplace.
Connects and relates well with people who think and act differently than oneself.
Embraces scrutiny and accepts feedback as opportunity to learn and improve.
Preparation of RA metrics for reporting purposes.
High attention to detail and process consciousness.
Strong IT skills, including Microsoft Office.
Russian - fluent, English - Intermediate
Travel Percentage: 10%