Job Description
Summary
Responsible for creating clear, accurate, and compliant labeling materials such as product labels, instructions for use (IFUs), and packaging inserts.
They ensure adherence to global regulatory standards (e.g., FDA, EU MDR), collaborate with cross-functional teams (e.g., regulatory, engineering, marketing, PLM, quality), and manage the review and approval processes.
Additionally, they manage labeling documentation, track revisions, and continuously improve labeling processes to ensure quality, safety, and regulatory compliance.
Key Duties and Responsibilities (Other duties may be assigned.)
Regulatory Compliance and Documentation
* Ensure Compliance: Ensure labeling content complies with global regulatory requirements (e.g., FDA, EU MDR, ISO 13485, etc.) and meets local language and format standards.
* Stay Updated on Regulatory Changes: Stay informed about changes to relevant medical device regulations and standards ...
Responsible for creating clear, accurate, and compliant labeling materials such as product labels, instructions for use (IFUs), and packaging inserts.
They ensure adherence to global regulatory standards (e.g., FDA, EU MDR), collaborate with cross-functional teams (e.g., regulatory, engineering, marketing, PLM, quality), and manage the review and approval processes.
Additionally, they manage labeling documentation, track revisions, and continuously improve labeling processes to ensure quality, safety, and regulatory compliance.
Key Duties and Responsibilities (Other duties may be assigned.)
Regulatory Compliance and Documentation
* Ensure Compliance: Ensure labeling content complies with global regulatory requirements (e.g., FDA, EU MDR, ISO 13485, etc.) and meets local language and format standards.
* Stay Updated on Regulatory Changes: Stay informed about changes to relevant medical device regulations and standards ...
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