What Are Some Of The Essential Roles And Responsiblities Of Regulatory Affair Engineers ?
Responsibilities:
Regulatory Affairs inputs for Risk Management Files, Compliance Plan and design requirements for safety (safety standards).
Work to continually improve operating excellence with regards to process execution.
Provide support during internal and external audits of the GEHC Quality Management System within respected areas.
Roles:
For supporting the global regulatory submissions which include maintaining and implementing the company's regulatory affairs systems.
-Supporting all global regulatory submissions
-Authoring global regulatory submissions
-Conducting training to other employees on regulatory matters
-Assisting with the reclassification process
-Developing, implementing and maintaining regulatory standard operating procedures
JOB SUMMARY: The Quality Assurance and Regulatory Affairs Engineer is responsible for the complete QA/RA responsibilities throughout the enterprise (Marketing, Sales/Service, Supplier, R&D, Manufacturing and Customer.)
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