Cynet systems Inc
Technical Writer - Assay Development
Cynet systems Inc, Tucson, Arizona, United States, 85718
Job Description
The Technical Writer will be responsible for creating, reviewing, revising, and approving documentation and labeling for Tissue Diagnostics products.
The role involves participating in project team meetings, providing updates to supervisors, and ensuring all documentation complies with relevant industry regulations and standards.
Responsibilities
Act as the Technical Writer on assigned project teams.
Attend project meetings and provide regular updates to the supervisor.
Create, review, revise, and approve documentation and labeling for Tissue Diagnostics products.
Ensure documentation meets applicable US and International regulatory standards.
Requirement/Must Have
3–5 years of direct documentation experience in the medical device, software, pharmaceutical, or biotechnology industry.
Knowledge of current US and International regulations related to documentation (e.g., FDA, ISO, IVDD, and 21 CFR 11) and control of electronic records.
Proven experience working on project teams and managing multiple projects simultaneously.
Should Have
Experience with international regulatory requirements (preferred).
Qualification and Education
Bachelor’s degree in a scientific discipline or other related technical field.
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The Technical Writer will be responsible for creating, reviewing, revising, and approving documentation and labeling for Tissue Diagnostics products.
The role involves participating in project team meetings, providing updates to supervisors, and ensuring all documentation complies with relevant industry regulations and standards.
Responsibilities
Act as the Technical Writer on assigned project teams.
Attend project meetings and provide regular updates to the supervisor.
Create, review, revise, and approve documentation and labeling for Tissue Diagnostics products.
Ensure documentation meets applicable US and International regulatory standards.
Requirement/Must Have
3–5 years of direct documentation experience in the medical device, software, pharmaceutical, or biotechnology industry.
Knowledge of current US and International regulations related to documentation (e.g., FDA, ISO, IVDD, and 21 CFR 11) and control of electronic records.
Proven experience working on project teams and managing multiple projects simultaneously.
Should Have
Experience with international regulatory requirements (preferred).
Qualification and Education
Bachelor’s degree in a scientific discipline or other related technical field.
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