Julia Johnston

• Execute the projects to schedule to minimize the impact of MDR
• Oversee multiple Sustaining/EU MDR initiatives to support risk mitigation of technical challenges
• Responsible for true project management activities (e.g., planning out the projects, ensuring deliverables are well defined, planning weekly meetings, etc.)
• Come from a medical device background and have experience overseeing similar projects in the EUMDR/medical device space
• Have prior experience leading sustaining projects and leading transfer projects
• Proven experience joining a Sustaining/Remediation project, helping to organize and complete the projects in a timely fashion, while also demonstrating fantastic communication skills

• Serve as the project manager and main liaison to the consultant and local H&B teams on smaller clients

• Create project plans, monitor progress from kickoff to project completion, scheduling and managing stakeholder communication

• Compose and edit final deliverables for client

• Managed approximately 15 projects at a time with a budget of approximately $2M

• Develop and implement strategic initiatives for Regional Hubs program
• Manage project timelines by tracking milestones and adjusting plans as needed
• Lead team meetings to discuss progress, address challenges, and motivate team members
• Engage stakeholders through regular updates and feedback sessions to foster collaboration

• Lead EU MDR remediation project planning for consumables, maintaining project
governance and partnering with Franchise Leads to ensure a harmonized approach for
achieving regulatory compliance
• Define and drive strategic objectives and deliverables through methodical planning, resourcing, and executing projects
• Collaborate with Subject Matter Experts to facilitate MDR product gap assessment and remediation efforts to ensure seamless execution of projects within timeline and
budget
• Develop, plan, communicate, and manage project timelines
• Communicate effectively with executive leadership and stakeholders to ensure clear expectations, demonstrate progress, and identify issues and find resolutions
• Negotiate and resolve conflicts and drive decisions among team and functional members to accomplish project and business goals
• Define and communicate project resource requirements and negotiate with functional managers to acquire resources vital for successful project completion

• Performing root cause analysis and incident management; providing technical support and instruction to team to resolve issues by developing and implementing solutions
• Communicating customer requirements, specifications, schedules, and budget constraints to cross-functional teams, including engineers, senior directors, and consultants
• Providing frequent and highly detailed presentations, communicating technical information regarding project updates, regulatory requirements, and timelines
• Establishing project schedules, financial parameters, and technical requirements while managing multiple projects simultaneously from initiation to completion
• Conducting internal audits to maintain regulatory compliance to customer specifications

• High-level change management strategic planning, incorporating input from stakeholders, change management directors, and workstream leads

• Designed business readiness strategies and project plans to ensure seamless transition and smooth operation post-dissolution of dedicated MDR teams

• Ensured all Legal Manufacturing sites met compliance requirements for EUMDR as well as applicable ISO and FDA standards

• Awarded "Rising Star - High Potential" designation

• Created, edited, and implemented global documents affected by EUMDR

• Maintained rigorous scheduling efficiency (number of projects increased by more than 50% of initial projection; I ensured all were completed on or before their respective deadlines)

• Trained contract workers at Legal Manufacturing sites
• Traveled internationally as needed, working weeks or months on-site to perform handson work that would ensure regulatory and audit compliance
• Prepared sites for Notified Body audits [successful preparation led to no major findings]
• Performed documentation audits for all Legal Manufacturing sites [18 projects at 7 sites; 126 projects in all]; designed schedules, orchestrated stakeholder
communication, performed thorough evaluation to meet goals and finished work two weeks ahead of deadline
• Taught technical writing workshops at international Legal Manufacturing sites