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Technical Document Reviewer
Summary of Position:
Our Technical Document Reviewers have a background in regulatory requirements applying to Medical device manufacturers' processes and products as well as knowledge of the Quality System Standard (ISO 13485). As technical file reviewer, assessing clients technical files and design dossiers, and other international market registration dossiers for new product submissions, new indications and claims for existing project lines, certification renewals, amendments and other associated activities to applicable government agencies. You are motivated to perform detailed investigation of complex technical issues. This requires working in a team environment, and reviewing the latest technologies.
Essential Duties and Responsibilities include the following. Other duties may be assigned to meet business needs.
Draw up medical test plans (MTP)
Execution of test plan
Review technical documentation and record review in a report.
Knowledge of applicable product standards and horizontal standards
Perform administrative tasks in projects.
Communicate with client about technical issues and progress
Involve experts (clinical, sterilization, etc.) as needed in execution of product reviews and in accordance with standards and regulations
Execution of projects in accordance with planned timelines.
Utilize knowledge of regulatory requirements applying to manufactures processes and products.
Review product design, engineering and manufacturing while documenting any deficiencies
Technical file reviews for clients utilizing analytical skills, technical knowledge and utilizing excellent written communication skills.
Utilize polished, professional presentation skills while communicating with clients to present DEKRA's findings
Work under directed supervision by Certified Senior Project Manager, and be able to assess compliance with regulatory requirements.
Maintain proficiency on global regulatory requirements and develop and maintain rapport with regulatory reviewers and project team members.
Create reports in a timely manner.
Handle multiple projects simultaneously in an efficient and effective manner.
Able to travel domestic and overseas up to 5% of the time, including overnight stays.
Available for communications in any time zone.
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