Primary Job Function
- Creation and maintenance of technical documentation that Authority requires in the approval process for medical devices according to local national and EAU legislations.
- Maintain strict timelines for technical, clinical/nonclinical documents
- Template development and maintenance of country specific labels according to local requirements for registered medical devices
- Create, update and maintain technical documentation in accordance with national standard templates and style guides in terms of content, format, and structure. (e.g. in Common Technical Document format) that summarize and discuss the data a company gathers in the course of developing a medical product.
- Interact directly and independently with R&D, Global Medical & Regulatory Affairs, Quality to ensure efficiency and completion of projects for authority submissions.
- Support other projects associated with Medical Writing / Regulatory Affairs.
- Act as Medical Writing Representative in cross-functional teams.
- Apply change control for technical documentation.
- Handle and verify translations prepared by Translation Agencies
- Use ADD’s different document management systems (e.g. APLM, ALMS, IRIS) to obtain, track, store specific technical data.
Education & Skills Required
- Technical degree / diploma in chemistry, biochemistry, biology or technical documentation, / technical writer.
- Exceptional writing ability with strong attention to grammar and punctuation.
- Good English language skills (written and spoken)
- Have expert computer skills
- In Quality, Documentation, Technical or Manufacturing areas.
- Experience writing clinical/regulatory documents preferred
JOB FAMILY:Regulatory Operations
LOCATION:Russia > Moscow : Metropolis Building 1
SIGNIFICANT WORK ACTIVITIES:Awkward/forceful/repetitive (arms above shoulder, bent wrists)