Quality-Focused SaMD Program Manager (Remote)

Eightelevengroup; Raritan (NJ); Remote; USD 120,000 - 160,000; Part time

Job summary

Medasource is seeking a Technical Project Manager for SaMD / GxP validation to lead a regulated imaging algorithm program in R&D IT, targeting a Q3 trial launch. You will own the plan, manage timelines, drive validation artifacts, and ensure QMS compliance with minimal onboarding.

The role requires proven experience in regulated software projects, familiarity with QA processes, and strong stakeholder management across Quality, Data Science and IT governance. Remote US-time zone work is supported.

Qualifications

• Proven experience managing technology or software projects in a regulated environment (life sciences, MedTech, 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.

Responsibilities

• 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.

Skills

Regulated software project management

QMS / Quality Management System

GxP validation

SaMD / imaging algorithm

UAT / validation documentation

Agile / Scrum

Stakeholder management

Self-sufficiency

Tools

Jira

TrueVault

Enterprise asset management system

Job description

Medasource is seeking a Technical Project Manager for SaMD / GxP validation to lead a regulated imaging algorithm program in R&D IT, targeting a Q3 trial launch. You will own the plan, manage timelines, drive validation artifacts, and ensure QMS compliance with minimal onboarding.

The role requires proven experience in regulated software projects, familiarity with QA processes, and strong stakeholder management across Quality, Data Science and IT governance. Remote US-time zone work is supported.