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:
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 Government (CFG), Certificate of Free Sale (CFS), and/or supporting documents from projects)
Respond to inquiries from the Company's local affiliates and proactively notify and coordinate with cross-functional teams including management any health authorityrelated questions or requests
Represent Regulatory Affairs on project teams and report regulatory requirements in the frequency, format, and sequence as required
Attend meetings and communicate with the project team as appropriate
Routinely communicate with regulatory management team regarding project status and deliverables
Support other regulatory activities as assigned
Minimum Requirements:
Bachelor's degree (life sciences preferred)
Minimum of 8-10 year of working experience in Regulatory Affairs focused on EU MDR
Knowledge of EU MDR, ISO13485, and FDA Medical Device regulations is mandatory
Working proficiency in Microsoft Office (e.g., Word, Excel, PowerPoint)
Strong written and verbal English communication skills required
