Sr. R&D Program Manager overseeing regulated digital health product lifecycle at Abbott. Leading cross-functional teams to ensure compliance and deliver successful product outcomes within healthcare innovation.
Responsibilities
Guide teams through regulated product lifecycles, including design and development or change plans, release management and post-market support.
Own the delivery of a digital product or suite of product development initiatives by creating integrated plans, cross-functional schedules and dependencies.
Coordinate the resolution of technical challenges and translate tradeoffs to business teams in clear business terms.
Facilitate operating cadence (cross-functional meetings, design reviews), safeguard documentation and compliance (robust design control traceability and audit-ready design history files), enforce stage-gate criteria and continuous risk reduction.
Coach and mentor junior staff on SaMD regulations and development strategies.
Partner with engineering, quality, regulatory, privacy, security and clinical teams to assess risks related to updates, design changes, platform changes or integrations ensuring that appropriate mitigations are defined and implemented.
Coordinate and advise across digital application efforts for a globally diverse, multi-product connected system.
Ensure compliance with all relevant standards and quality expectations for digital health and software as a medical device.
Requirements
10+ years in program/project management
5+ years in regulated digital health or software
Bachelor’s degree in engineering or science equivalent
Ability to travel 10% of the time, including internationally
Strong leadership and communication skills across multiple levels of the organization
3+ years of experience directly managing technical staff
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