Job Description
Responsibilities:
- Actively collaborate with the client's regulatory project team to identify and collect all necessary TF/DD documents in compliance with EU MDR (2017/745) and related guidance (MDCGs) for maintenance and resubmission. The high-level activities may include but are not limited to:
- Identify applicable regulatory requirements, harmonized standards, guidance documents, and submission expectations
- Review, obtain, and combine TF/DD documents in PLM or similar regulatory sources into Adobe PDF files
- Create and upload bookmarks/indexes of the Adobe PDF files into PLM via Change Orders.
- Perform Quality Control checks in accordance with client procedures, training, and checklists, including verification of completeness, correct pagination, and absence of blank or missing pages
- Work with cross-functional teams and affiliates to obtain necessary legal documents (e.g., Certificate to Foreign Governm...
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