Our Client is looking for a Project Coordinator to coordinate and/or perform tasks and project work in support of international regulatory requirements.
- Collect and enter global UDI attributes and global labeling information into predefined systems
- Assist with collation of information for Technical Documentation Files and Declaration of Conformities
- Manage OEM / Accessory Declarations of Conformity and Certification
- Assistance with regulatory agency deliverables when applicable
- Support regulatory registration information entries into specialized software applications
- Update RRA (Regulatory Release Authorization) when product registration for a country is completed
- Create and maintain appropriate work instructions
- Update and maintain product lists for FDA, Notified Body and other regulatory bodies that contain applicable clearance/approval pathway
- Execute identified tasks for the Global Growth Project, including drafting and launching Engineering Change Orders (ECO), labelling updates, and working with manufacturing to implement the changes and update Device History Records (DHR)
- Engage in clear and timely communication with Regulatory Affairs, Marketing and Customer Service teams
- Provide skilled technical support with minimal direction, which may include data coordination, data analysis, tracking and coding
- Perform other related duties as assigned Education & Special Trainings
- Intermediate knowledge of Microsoft Office applications (Outlook, Word, Excel, PowerPoint, Access)
- High attention to detail within data entry a must
- Must possess strong oral and writing communication skills
- Excellent customer service and desire to assist internal and external customers
- Must manage tasks in a timely manner and prioritize work effectively
- Able to work in a fast moving and ever-changing environment
- Plans, monitors, and manages internal projects from initiation through completion.
- Secures required resources and uses formal processes and tools to manage resources, budgets, risks, and changes.
- Manages projects to ensure on-time completion according to specifications and within budgeted costs.
- This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision.
- Roles typically require a university degree or an extensive amount of practical knowledge gained through experience.
- An understanding and application of procedures and concepts of own discipline.
- Ability to make judgements based on practice and previous experience.
Reference Number: 5626