Regulatory Program Lead – Diagnostics & Submissions

Becton, Dickinson and Company

San Diego (CA)

On-site

USD 130,000 - 207,000

Full time

3 days ago

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Job summary

Becton, Dickinson and Company is seeking a Program Manager to lead regulatory readiness for technical documentation across in-market clinical diagnostic products. You will coordinate Regulatory Affairs, R&D, Quality, and other functions to ensure timely, compliant submissions and re-registrations.

The role requires strong program management in a regulated environment, with a focus on end-to-end documentation, risk management, and cross-functional collaboration to support global product

Qualifications

6+ years in life sciences/regulatory
3+ years leading cross-functional initiatives
Experience with regulatory submissions and compliance programs
Experience with product lifecycle management is a plus

Responsibilities

Lead a cross-functional regulatory compliance program for clinical diagnostic products.
Develop and maintain integrated program plans, timelines, milestones, and resources.
Coordinate activities across Regulatory Affairs, R&D, Quality, Medical Affairs, Marketing, Operations, Supply Chain.
Drive remediation plans and ensure documentation is compliant and traceable.
Maintain program dashboards, risk logs, and status reports.

Skills

Program management

Cross-functional leadership

Regulatory knowledge

Risk management

Executive communication

Education

Bachelor's degree in science/engineering/regulatory

MBA/MS/PhD preferred

Tools

MS Office

Project

Job description

The role requires strong program management in a regulated environment, with a focus on end-to-end documentation, risk management, and cross-functional collaboration to support global product

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