Technical Project Manager – SaMD​/GxP Validation

We need an independent, Quality-first project manager to drive an imaging algorithm Software as a Medical Device (SaMD) program in R&D IT toward a trial launch targeted for Q3. You will run the plan, clear blockers and own the validation documentation, all within a regulated Quality Management System (QMS). This is a technology role, not clinical operations, and we want someone who can start delivering in week one.

• Engagement: 12-month contract
• Location:
  
  Fully remote (US time zones)
• Start:
  Targeted before the end of 2026, continuing into 2027
• Focus:
  SaMD imaging algorithm program, R&D IT
• Milestone:
  Trial launch targeted for Q3
• Rate:
  Market rate, to be confirmed

• Own the plan. Build and maintain timelines, track milestones and coordinate deliverables across the SaMD imaging program.
• Run the cadence. Lead sprint planning and cross-functional meetings, and keep the team moving without ceremony for its own sake.
• Remove roadblocks. Spot risks early and drive them to resolution.
• Protect Quality. Make sure every step follows the established Quality System processes, validation rules and launch compliance requirements.
• Own QMS documentation. Author, review and cite required records, including User Acceptance Testing (UAT) materials, participant documentation and validation artifacts. Complete the training needed to review and approve Quality System documents.
• Make the algorithm assessable. Ensure information on the imaging algorithm’s functionality and intended use is available for review.
• Coordinate stakeholders. Partner with Data Science leads, Quality and IT governance to work through validation reviews and secure approvals.
• Operate independently. Work with minimal oversight, with guidance available from the program lead.

• Proven experience managing technology or software projects in a regulated environment (life sciences, Med Tech, medical device or similar).
• Working knowledge of how to run a project inside a Quality Management System: documented procedures, approvals, change control and audit-ready records.
• Familiarity with SaMD frameworks and GxP software validation.
• Experience writing and reviewing validation and UAT documentation.
• Agile and Scrum fluency, applied with a Quality mindset rather than as ceremonies alone.
• Strong stakeholder management with Quality, Data Science and IT governance teams, including the ability to win over skeptics.
• Self-sufficiency: you can start without extensive onboarding or training in regulated project management.

• Direct SaMD, medical device software or Med Tech project experience.
• Experience in large, matrixed life sciences or Med Tech organizations. J&J Medtech preferred.
• Experience with imaging or algorithm-based (AI/ML) software products.
• Background in other regulated industries is welcome if the Quality and validation experience is strong.

Hands-on use of Jira, True Vault (or a comparable validated document or records system) and an enterprise asset management system is helpful. No single platform is a hard requirement; experience working inside regulated, tool-governed processes counts more than any one product.

• The program stays on track for the Q3 trial launch, with timelines and milestones current and visible.
• UAT, validation and QMS documentation is complete, cited correctly and approved on schedule.
• Quality, Data Science and IT stakeholders trust the plan and the person running it.
• The program runs with little oversight, and its results show whether more project management support is worth adding.