- Under general direction, responsible for the leadership and direction moderate to high complexity projects with considerable resources, particularly related to EU Medical Device Regulation compliance and other regulatory / quality initiatives.
- Responsible for all aspects of the project management from initiation to completion and interfacing with all stakeholders to ensure successful and timely results.
- Interface and work collaboratively with peer project managers, program lead, subject matter experts.
- Identify resource needs, assemble project teams, assign responsibilities and develop schedules to ensure timely completion of projects.
- Project budget estimation, monitoring and attainment through the project lifecycle.
- Ensuring common understanding by setting expectation in accordance with the project plan in order to align the stakeholders and team members.
- Lead in identification, assessment, monitoring and closure of project risks throughout the project lifecycle.
- Manage changes to project scope, project schedule and project costs using appropriate verification techniques in order to keep project plans accurate, updated and reflective of authorized changes to facilitate acceptance
- Responsible for improving team performance by building team cohesiveness, leading and motivating in order to facilitate cooperation, ensure project efficiency and boost morale.
- Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions and communicate to all stakeholders.
- Assist in developing best practices and benchmarking opportunities for the team and peer project managers.
- A minimum of 5 years’ experience in Project Management
- Demonstrated experience managing high responsibility, high visibility projects / programs of various sizes
- Demonstrated experience with project management methodologies, technologies, tools, etc. and the documentation software to maintain project records
- Ability to generate and explain detailed proposals, schedules, objectives, budgets, report-outs and other documentation accurately.
- Experience working in a regulated environment preferred
- Experience working with cross-functional teams preferred
- Management of projects associated with quality / regulatory / compliance related initiatives preferred
- Knowledge of quality systems and EU regulatory requirements including the MDD and MDR for medical devices is advantageous
- Cross-functional, collaborative, team-based work experience preferred
- Strong interpersonal, negotiation, communication (presentation, written & oral) and organizational skills
- Ability to build trusting relationships within project teams and to communicate to all levels of an organization
- Experience with Windchill PLM (preferred), MS Project / Project Online (essential).
- 4 year degree; PMP certification or similar preferred.
- 5% Travel
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