Job Description

• Excellent written and verbal communication skills and interpersonal relationship skills
• Good ability to read, write and speak English
• Solid knowledge and understanding of Edwards policies, procedures, and regulatory (e.g., medical, pharmaceutical) guidelines relevant to documentation
• Solid understanding of medical device documentation development activities
• Ability to manage confidential information with discretion and attention to detail
• Contributes to the completion of more complex organizational projects and goals
• Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

• Manage DCC (document control center) operation by processing and retrieving documents and sending to internal or archiving
• Lead special projects (e.g., documentation remediation) in collaboration with team members; identify opportunities for process improvement including developing and proposing solutions, and proposing new processes and system enhancement
• Ensure compliance with internal procedures, coordinate and perform incorporation of approved changes to documentation (e.g. verify track changes to update drawing documents) and verify correct implementation to comply with EW and Local Regulatory Requirements
• Responsible for final documentation review by processing, reviewing, and releasing product at distribution center and RLRP (right label right product)
• Create labeling contents including add-on label, IFU and preprinted artwork with collaborating with vendors and internal stakeholders
• Evaluate changes proposed by initiators and provide feedback

• Medical Leave
• Insurance Benefits