The primary role of the Regulatory Affairs Project Manager is to provide support for the daily activities associated with global regulatory projects, including communicating with the various teams on regulatory projects.
- Establish project plans with associated milestones and deadlines
- Communicate with stakeholders throughout projects
- Act as a single point of contact and provide coordination of deliverables
- Develop strong relationships with all stakeholders to create high-functioning global project teams
- Ensure that projects are completed on schedule and with appropriate documented approvals
- Oversee routing, tracking, and archiving of project documentation
- Identify, document, and facilitate resolution of project risks and issues
- Provide coaching and guidance to relevant team members in best project practices
- Develop and review project status reports with relevant team members. Follow up on needed changes as required
- Develop and document resource information and summaries
- Facilitate project status meetings and other meetings as required
- Ensure training completed for users on new systems and processes
- Must comply with quality management system requirements
- Perform additional duties as assigned
- Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf
- Third level Qualification at degree level desirable
- Two years’ experience in a similar role is desirable
- Project management certification an advantage
- Knowledge of medical device industry desirable
- Strong strategic, problem solving and analytical abilities, diplomacy, negotiation, and excellent oral and written communications skills. Incumbent must have the ability to present facts and recommendations effectively in oral and written form
- Proven ability to interact in a group environment throughout various levels of the global organization, have strong interpersonal skills and the ability to establish and maintain effective relationships with all stakeholders. Must be a strategic team builder with good business acumen, combined with hands-on approach.
- Highly organised. A detail-oriented work style and the ability to handle multiple tasks. Must be able to work under pressure and meet deadlines.
- Ability to work in collaborative and independent work situations and environments with minimal supervision.
- Ability to remain calm and receptive in fast paced situations.
- Proficient use of computers and use of Microsoft Office applications is required. Additional experience with databases and report writing is a plus.
- Willingness and availability to travel on company business.
- High self-motivation.
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