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

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters' innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters' passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

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Job Description

Position Summary

The Program Manager will lead a cross-functional initiative focused on assessing and improving the regulatory readiness of technical documentation for in-market clinical diagnostic products. This role will partner closely with Regulatory Affairs, R&D, Quality, Marketing, Medical Affairs, Operations, and other stakeholders to support global product registrations, re-registrations, and regulatory submissions.

The successful candidate will establish and maintain integrated program plans, coordinate technical dossier reviews, facilitate identification of documentation and compliance gaps, and drive the development and execution of remediation plans. This individual will serve as the central point of coordination across multiple functions to ensure timely completion of deliverables, proactive risk management, and alignment with regulatory requirements and business priorities.

This role requires a strong foundation in program management, cross-functional leadership, and execution within a regulated environment. The ideal candidate will bring structure, accountability, and disciplined program management practices to complex initiatives involving multiple products, stakeholders, and competing priorities.

Key Responsibilities

Program Leadership & Execution

• 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.

Technical Dossier Assessment & Remediation

• Coordinate systematic reviews of technical documentation to assess readiness for regulatory submissions and product re-registrations.
• Facilitate cross-functional assessments to identify missing, outdated, incomplete, or potentially non-compliant documentation.
• Partner with subject matter experts to define remediation plans, required deliverables, ownership, and timelines.
• Monitor execution of remediation activities and proactively address barriers to successful completion.
• Ensure documentation assessments and remediation activities are appropriately documented and tracked.

Risk Management & Governance

• Identify, assess, and manage program risks related to schedule, resources, technical documentation, regulatory compliance, and business continuity.
• Facilitate development of mitigation and contingency plans to address identified risks.
• Lead cross-functional program meetings, working sessions, and governance reviews.
• Maintain program dashboards, action-item logs, decision logs, risk registers, and status reports.
• Escalate significant issues, resource constraints, and compliance risks to leadership as appropriate.

Regulatory & Quality Compliance

Partner with Regulatory Affairs to understand submission requirements and ensure program plans support regulatory objectives.

Support readiness for regulatory submissions, audits, inspections, and co