Project Manager The role
This is a crucial role in driving innovation, quality, and efficiency in our development processes. The Project Manager is responsible for overseeing and managing all aspects of new product development and product change projects from the project initiation to the launch. This role requires a strong combination of project management expertise, knowledge in the medical device field, as well as communication, facilitation and leadership skills. The Project Manager will coordinate cross-functional, international and multi-site teams to ensure the successful execution and delivery of projects on time, within budget, and in compliance with regulatory requirements.
Key responsibilities Project Planning and Strategy:Develop comprehensive project plans.Collaborate with stakeholders to establish project scope and milestones.Identify project risks and develop strategies to mitigate them.Project Execution, Monitoring and Control:Lead cross-functional, international and multi-site teams.Monitor project progress, identify bottlenecks, and take corrective actions to keep projects on track.Project Closure:Ensure the overall scope of the projects, its objectives and deliverables are ready for successful launch.Quality Assurance and Regulatory Compliance:Collaborate with regulatory affairs and quality assurance teams to ensure compliance with applicable regulations, standards, and guidelines.Implement design controls and risk management processes to ensure safe and effective medical devices and medical software releases.Stakeholder Engagement and Collaboration:Build strong relationships with stakeholders, promote collaboration, and manage expectations.Effectively communicate project progress, risks, and issues to stakeholders at various levels.Continuous Improvement:Conduct post-project evaluations, review, and formulate lessons learned for future projects.Categoria: Healthcare / Pharmaceutical
Luogo di lavoro: Padova
Requisiti: Proficiency (level C2) in English, written and spoken.Excellent communication and presentation skills.Proven experience (minimum 5 years) in managing medical device (and/or medical software) development projects.Strong knowledge of medical device development processes, including design controls, risk management, and regulatory requirements.Excellent project management skills, including planning, execution, and monitoring with a focus on prioritization and meeting deadlines.Leadership abilities, with a track record of successfully leading and motivating cross-functional teams.Excellent communication, negotiation, and stakeholder engagement skills.Strong analytical skills and the ability to manage systematically the changing project requirements.Attention to detail and ability to manage multiple interrelated projects simultaneously.Knowledge of relevant regulations and standards, such as FDA regulations (e.g., 21 CFR Part 820), ISO 13485, and ISO 14971. Knowledge about clinical trials would be beneficial.Project management certifications (e.g., PMP) are highly desirable.Proficiency in project management tools and software.
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