CorDx ยท 3 weeks ago
Senior Project Manager (San Diego) - Bilingual (Mandarin Speaking)
San Diego, CA
Full-time
Onsite
Senior Level
$80K/yr - $120K/yr
5+ years expCorDx is a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. They are seeking a highly motivated and experienced Senior Project Manager to lead and support cross-functional projects within their In Vitro Diagnostics and broader diagnostics portfolio, ensuring project goals, timelines, and budgets are met while maintaining alignment with company strategy and regulatory requirements.
Health CareHealth DiagnosticsMedicalMedical Device
Responsibilities
Manage cross-functional project teams across R&D, Regulatory Affairs, Clinical, Quality, Operations, and Commercial functions to deliver IVD/diagnostic products from feasibility through commercialization
Develop and maintain comprehensive project plans, schedules, and budgets, tracking milestones, dependencies, and deliverables
Monitor and report on project status, risks, and issues, providing clear updates to project stakeholders and senior leadership
Coordinate resources and align priorities across internal departments to support timely and efficient project execution
Support regulatory submission readiness activities, ensuring projects comply with applicable regulatory and quality standards (e.g., FDA, ISO 13485)
Facilitate regular project meetings, including team updates, risk reviews, and issue resolution sessions
Assist in managing external vendors and partners involved in development, manufacturing, or other project-related activities
Contribute to continuous improvement initiatives in project management processes, tools, and methodologies
Maintain accurate project documentation and support governance processes, including project reviews and stage-gate decision-making
Qualification
Required
Bachelor's degree in Life Sciences, Engineering, Business, or a related field; advanced degree (MS, MBA) preferred
5-8 years of project management experience in the biotech, diagnostics, or medical device industry, with a focus on product development in a regulated environment
Solid understanding of regulatory pathways, quality systems (e.g., ISO 13485), and product commercialization processes for IVDs or medical devices
Proven ability to manage cross-functional project teams and deliver projects on time and within budget
Life Science/IVD industry experience highly preferred
PMP certification or formal training in project management strongly preferred
Excellent organizational, leadership, and interpersonal skills
Ability to work effectively in a dynamic, fast-paced environment with shifting priorities
Preferred
Experience supporting global product launches and managing distributed or cross-site teams
Familiarity with project management software and tools
Exposure to Agile or Stage-Gate development methodologies
Strong problem-solving, critical thinking, and decision-making abilities
Prior experience working with external partners and managing vendor relationships is a plus
Benefits
Comprehensive medical, dental, and vision insurance
401(k) plan with generous company contributions
Flexible paid time off (PTO) policy
Additional substantial benefits
Company
CorDx
CorDx provides medical device solutions to the healthcare industry.
1001-5000 employees
H1B Sponsorship
CorDx has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2023 (2)
Funding
Current Stage
Late StageRecent News
2025-03-26
Company data provided by crunchbase