What are the responsibilities and job description for the Regulatory Affairs Labeling Specialist position at Compunnel?
Description : Laptop will not be issued. Operates complex equipment and analytical tools, processes, state of the art 12'' silicon wafers in a clean room environment, which requires appropriate gowning.
Technicians are owned in a gore suit that covers them from head to toe as they perform their work duties.Multi-tasked responsibilities may include minor preventative maintenance, troubleshooting, non-standard processing and problem-solving.
Primary job duties are to perform a - Variety of routine operations supporting wafer fabrication in a specific functional area.
Position requires working efficiently from standard procedures and specifications. Technicians work 12 hour shifts and spend the majority of their time standing to perform the work.
Some, if not all, tasks performed require repetitive motion to an extent. Candidate must have : 1 - 3 years work experience in Semiconductor cleanroom.
1 - 3 years work experience in production and / or office work, or trade with a focus on utilizing computers / software.
AA degree in related field, including computer software, semi conductor, etc.Maintains current knowledge of the development and changes to applicable laws, regulations and industry standards for global markets, providing guidance ininterpreting regulations and agency guidelines.
Initiates, reviews and approves technical documentation, product labeling, and product instructions for use changes for compliance with applicable regulations.
Trains to andexecutes document management within local ProductLifecycle Management system and other electronic documentation systems as applicable.
Updates and maintains product registrations with US FDA and EU Notified Body to assure compliance with applicable global regulatory requirements.
Other activities as assigned.
Education : Bachelors Degree
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