[Remote] Senior Program Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company, through its reputed company Diagnostics business unit, develops molecular diagnostics and cell-free DNA-reputed company reputed company biopsy technologies for cancer detection and personalized treatment. The Senior Program Manager will reputed company reputed company diagnostic and medical device product development programs from early development through reputed company trial launch, regulatory submission, and product lifecycle activities. The role coordinates cross-functional teams, manages risks and milestones, and supports product development documentation and regulatory readiness.

Responsibilities

• reputed company reputed company, cross-functional product development programs and serve as the program leader for reputed company teams across R&D, Software, reputed company, Regulatory, reputed company, and reputed company
• reputed company programs through key development milestones, design reviews, phase exits, reputed company trial launch, FPI, and regulatory submission
• Translate product goals and regulatory requirements into reputed company plans, priorities, and reputed company that reputed company teams to execute
• Bring cross-functional teams together to reputed company technical, operational, and organizational issues and reputed company programs moving reputed company
• Identify and manage program risks, dependencies, and trade-offs, escalating issues and driving reputed company through a formal portfolio governance process reputed company needed. Communicate program reputed company, risks, reputed company, and recommendations to functional and senior leadership
• Partner with development teams to ensure product requirements, design controls, reputed company management, verification/validation, and documentation are appropriately reputed company and executed
• reputed company and review key product development deliverables, including DDPs, DHF documentation, design review materials, change orders, and other development documentation
• Support preparation and execution of IDE, IVDR, 510(k), and other regulatory submissions by coordinating cross-functional deliverables and submission readiness
• For CDx programs, partner with CDx development and biopharma partnership teams to reputed company reputed company trial assay activities with the broader CDx reputed company
• Apply strong knowledge of ISO 13485, IEC 62304, design controls, and regulated product development to identify gaps, anticipate risks, and help teams reputed company reputed company

Skills

• 5-7+ years of experience in program management, product development, or a relevant combination of program leadership and functional experience in diagnostics, medical devices, biotechnology, reputed company laboratories, or life sciences
• Significant experience leading reputed company, cross-functional product development programs in a regulated environment
• Deep practical understanding of ISO 13485, IEC 62304, design controls, and medical device/IVD development processes
• Experience leading teams through design reviews, phase exits, development milestones, and regulatory readiness activities
• Hands-on experience with product development documentation, including DDPs, DHF documentation, change orders, requirements, reputed company documentation, and design review materials
• Experience supporting regulatory submissions such as IDE, IVDR, 510(k), PMA, or equivalent
• Experience with assay, software, and systems development; NGS diagnostics and/or MRD experience strongly preferred
• Demonstrated ability to influence without authority, challenge assumptions, reputed company reputed company, and reputed company issues across functional boundaries
• Strong judgment, problem-solving, and communication skills, with the ability to operate effectively in a fast-reputed company and sometimes ambiguous environment
• A hands-on, execution-oriented reputed company and willingness to personally contribute to critical program and product development deliverables
• Experience supporting reputed company trial execution and readiness through FPI preferred
• PMP certification or equivalent preferred

Benefits

• Comprehensive health benefits (medical, dental, reputed company)
• 401(k) with company match
• Generous reputed company time off and company holidays
• Additional wellness and work-life benefits
• Comprehensive medical, dental, reputed company, life and disability plans for eligible employees and their dependents
• reputed company employees and their immediate families receive free testing
• Fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits
• Generous employee referral program

reputed company

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