What are the responsibilities and job description for the Technical Writer/Coordinator position at Katalyst Healthcares & Life Sciences?
Responsibilities:
- Ensures that the various types of documentation are accurate, readable, well organized and geared toward the intended user of the documentation
- Ensures that the documents conform to applicable regulatory requirements and ISO 13485 standards
- Applies skills and develops documentation including operating procedures, process flow charts and procedures
- Identifies and implements improvements to the overall document organizational change process
- Creates and submits new documents or document revisions into the document control system and tracks them to release
- Schedules review meetings and conducts training to the document changes, as necessary
- Coordinate document requests and stage documents for presentation during regulatory inspections and internal audits
- May coordinate activities with others and/or perform other related duties and responsibilities, as assigned, in relationship to complaint handling and adverse event reporting
- May need to create customer letters, mailing labels, and other duties as assigned in support of the post market surveillance teams
- Must have grammar and the ability to communicate correctly and persuasively
- Works independently with minimal guidance
- Excellent writing skills
- Ability to navigate formatting and review functions in Microsoft products
- Experience in quality management systems within the medical device industry, preferred
- Familiarity with document management systems
- Bachelor's degree, preferred or equivalent experience
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