Senior Project Manager

CorDx • Atlanta, GA

201d

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

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.

Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(k) plan with generous company contributions.
• Flexible paid time off (PTO) policy.
• Additional substantial benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees