Project Manager - EUMDR

Relevant Experience

(in Yrs)

A minimum with 2+ years of related experience in EU MDR domain in Medical Device Industry

Technical/Functional Skills

• Knowledge on Medical Device Regulatory Standards
• Documentation skills relevant to EU MDR
• Knowledge on Quality Management and its tools & techniques
• Knowledge about FDA, ISO 13485 and compliance regulations
• Demonstrated understanding of compliance requirements for medical devices preferred
• Technical Writing skills and experience preferred
• PLM System and ERP System knowledge
• Demonstrated leadership of projects across quality systems, plants, and regions preferred
• Knowledge in Statistic, Risk Management, Design and Change control
• Excellent Microsoft Project Management and Presentation Skills (Power point Presentation)
• Must possess good communication skills (verbal and written) and problem-solving skills

Experience Required

4+ Years

Roles & Responsibilities

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the duties and responsibilities for this position are:

• Lead and Manage EU MDR related activities within CSS
• Plan, execute, and communicate project deliverables
• Responsible for leading collaboration for EU MDR changes between PM Lifecycle Product Managers, Quality, Regulatory, Marketing, and packaging associates for prioritization and execution strategies
• Develop project team and provide required training and guidance
• Develop project plan and streamline project to ensure all the relevant milestones are achieved in compliance with the project plan
• Meet with project core team to review requirements and deliverables of each project
• Setup project governance
• Ensure stakeholders understand outputs of all decisions and track project status
• Accountable for working with planning for phase in/phase out of changes considering commercial, quality or regulatory strategies and insuring implementation
• Responsible for communicating business related issues or opportunities to next management level
• Complete training in area of responsibility within allowed time-period. Training is required for changes in existing policies & procedures, for new assignments & for implementation of new policies & procedures.

• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance
• Responsible for ensuring that subordinates follow all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
• Performs other duties assigned as needed