Regulatory Readiness Program Manager

Becton Dickinson; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Waters is seeking a Program Manager to lead cross-functional efforts improving regulatory readiness and technical documentation for in-market clinical diagnostic products. You will partner with Regulatory Affairs, R&D, Quality, Marketing, Medical Affairs, and Operations to drive global registrations and submissions.

The role requires strong program management, governance, and risk management practices in a regulated environment to ensure timely, compliant deliverables across multiple products.

Responsibilities

• Lead a cross-functional regulatory compliance program supporting technical dossier audits and regulatory readiness assessments for commercialized clinical diagnostic products.
• Develop and maintain integrated program plans, timelines, milestones, dependencies, and resource requirements.
• Coordinate activities across Regulatory Affairs, R&D, Quality, Medical Affairs, Marketing, Operations, Supply Chain, and other functional teams.
• Establish clear program objectives, deliverables, schedules, and accountability mechanisms to support successful execution.
• Drive timely completion of program deliverables while balancing regulatory requirements, business priorities, and resource constraints.
• Ensure stakeholders remain informed of program status, key decisions, risks, and upcoming milestones.

Job description

Waters is seeking a Program Manager to lead cross-functional efforts improving regulatory readiness and technical documentation for in-market clinical diagnostic products. You will partner with Regulatory Affairs, R&D, Quality, Marketing, Medical Affairs, and Operations to drive global registrations and submissions.

The role requires strong program management, governance, and risk management practices in a regulated environment to ensure timely, compliant deliverables across multiple products.