Project Manager - Medical Devices

Project Manager - Medical Devices High Wycombe Paying up to £67,500 Are you a Project Manager and looking for that next step up? Where you will be in total charge of all projects and line managing staff? You may not be actively looking, but this is a newly created role where you can truly make it your own. You will need to have worked with Medical Devices in some capacity so experience of this is a must have (but it doesn't have to be recent, just as long as you have before). What’s In It for You? * Impactful Work: You'll play a critical role in bringing life-changing medical devices to market, ensuring they meet the highest regulatory standards and are backed by robust clinical evidence. * Professional Development: You'll have access to ongoing training and development programs, including support for certifications and attendance at industry conferences, to keep you at the forefront of regulatory and clinical expertise. * Innovative Environment: Work alongside a talented, multidisciplinary team in a company that values creativity, innovation, and continuous improvement. * Work-Life Balance: You will likely be asked to leave at 5pm to go home and enjoy your personal time, this company fosters a fantastic culture where your wellbeing is of utmost importance. What you will be doing... * Project Leadership: As assigned, you will lead regulatory and clinical projects of varying scope and size through the project lifecycle. Examples of projects include, but are not limited to: * MDR Submissions / MDR Technical File Reviews / Remediation, including acting as the point of contact for external contractors (where required). * New Product Introduction Projects. * Foreign Market Product Registrations. * Management of Regulatory CAPAs. * Continuous Improvement projects, as identified. * Project Documentation: Ensure that project documentation is up to date and reported in a timely manner. * Compliance Implementation: Through project management, you will be responsible for the implementation of new Medical Device Files to ensure compliance with all applicable regulatory requirements. * Technical Reporting: Produce technical reports as required. * CAPA Management: Manage CAPAs and associated documentation, including investigation and root cause activities. * Additional Responsibilities: Carry out any other duties as requested by the Senior Compliance Manager or Leadership Team that are reasonable in relation to promoting the company image or products. What we need from you: * Hold a Prince2 or other established project management methodology qualification. * Have a highly disciplined and detailed approach to project management and associated timelines. * Have experience of Line Management and task delegation. * Experience of working with Medical Devices