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.

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

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 compliance reviews.
• Ensure program activities are conducted in accordance with applicable quality systems, document control requirements, and regulatory expectations.
• Work closely with Quality and Regulatory Affairs to ensure appropriate documentation standards are maintained.
• Promote a culture of compliance, accountability, and continuous improvement across the program team.

Continuous Improvement

• Identify opportunities to improve documentation management, regulatory readiness processes, and program execution practices.
• Recommend and implement process improvements that enhance efficiency, transparency, and compliance.
• Apply program management best practices to improve planning, communication, risk management, and stakeholder alignment.

Minimum Qualifications

Education

• Bachelor's degree in a scientific, engineering, technical, regulatory, or related discipline. Postgraduate degree, such as an MBA, MS, or PhD, is preferred.

Experience

• Minimum of 6 years of experience in the life sciences, biotechnology, medical device, diagnostics, or other regulated industry.
• Minimum of 3 years of experience leading projects or other cross-functional initiatives.
• Experience supporting complex programs involving multiple stakeholders, deliverables, and competing priorities.
• Experience with technical documentation, quality systems, regulatory submissions, compliance programs, or product lifecycle management is preferred.
• Experience supporting medical device or in vitro diagnostic (IVD) products is preferred.
• Project Management Professional (PMP) certification is a plus but not required.

Knowledge, Skills & Abilities

• Strong program and project management skills, including planning, execution, risk management, and stakeholder communication.
• Demonstrated ability to lead and influence cross-functional teams in a matrix organization.
• Strong analytical, organizational, and problem-solving capabilities.
• Ability to manage multiple priorities and maintain attention to detail while keeping a broader program perspective.
• Excellent written, verbal, facilitation, and presentation skills.
• Experience developing executive-level status reports, dashboards, and program metrics.
• Ability to drive accountability and achieve results without direct reporting authority.
• Working knowledge of regulatory and quality system requirements within a regulated industry.
• Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Project.
• Experience with document management, product lifecycle management, or project management systems is preferred.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA CA - San Diego (BDB)

Additional Locations

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$129,600.00 - $207,400.00 USD Annual