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CorDx
San Diego, CA, USA
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ShareWho is CorDx CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious diseases such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Job Type: Full time Job Title: Senior Project Manager Location: Onsite - San Diego, CA Job Overview: We are seeking a highly motivated and experienced Senior Project Manager to lead and support cross-functional projects within our In Vitro Diagnostics (IVD) and broader diagnostics portfolio. This role will be responsible for managing projects from early development through launch, ensuring project goals, timelines, and budgets are met while maintaining alignment with company strategy and regulatory requirements. The ideal candidate will bring strong project management skills, a solid understanding of the biotech or medical device industry, and the ability to drive results through leadership, organization, and effective communication. Key Responsibilities: Manage cross-functional project teams across R&D, Regulatory Affairs, Clinical, Quality, Operations, and Commercial functions to deliver IVD/diagnostic products from feasibility through commercialization. Develop and maintain comprehensive project plans, schedules, and budgets, tracking milestones, dependencies, and deliverables. Monitor and report on project status, risks, and issues, providing clear updates to project stakeholders and senior leadership. Coordinate resources and align priorities across internal departments to support timely and efficient project execution. Support regulatory submission readiness activities, ensuring projects comply with applicable regulatory and quality standards (e.g., FDA, ISO 13485). Facilitate regular project meetings, including team updates, risk reviews, and issue resolution sessions. Assist in managing external vendors and partners involved in development, manufacturing, or other project-related activities. Contribute to continuous improvement initiatives in project management processes, tools, and methodologies. Maintain accurate project documentation and support governance processes, including project reviews and stage-gate decision-making. Requirements Qualifications: Bachelor’s degree in Life Sciences, Engineering, Business, or a related field; advanced degree (MS, MBA) preferred. 5-8 years of project management experience in the biotech, diagnostics, or medical device industry, with a focus on product development in a regulated environment. Solid understanding of regulatory pathways, quality systems (e.g., ISO 13485), and product commercialization processes for IVDs or medical devices. Proven ability to manage cross-functional project teams and deliver projects on time and within budget. Life Science/IVD industry experience highly preferred. PMP certification or formal training in project management strongly preferred. Excellent organizational, leadership, and interpersonal skills. Ability to work effectively in a dynamic, fast-paced environment with shifting priorities. Preferred Skills & Competencies: Experience supporting global product launches and managing distributed or cross-site teams. Familiarity with project management software and tools. Exposure to Agile or Stage-Gate development methodologies. Strong problem-solving, critical thinking, and decision-making abilities. Prior experience working with external partners and managing vendor relationships is a plus. Benefits Comprehensive medical, dental, and vision insurance. 401(k) plan with generous company contributions. Flexible paid time off (PTO) policy. Additional substantial benefits. Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.
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Bethesda, MD, USA
