Abbott Regulatory Medical Writer in Moscow, Russia

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

Major Responsibilities

  • 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 at https://en.wikipedia.org/wiki/CommonTechnicalDocument 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

Background

  • In Quality, Documentation, Technical or Manufacturing areas.

  • Experience writing clinical/regulatory documents preferred

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com