Job DescriptionPosition SummaryThe 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 ResponsibilitiesProgram 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- Facilitate cross-functional assessments to identify missing, outdated, incomplete, or potentially non-compliant documentation.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 QualificationsEducation- 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.
Primary Work LocationUSA CA - San Diego (BDB)
Salary Range Information$129,600.00 - $207,400.00 USD Annual
