Remote SaMD Imaging Program Manager (GxP)

Medasource; Raritan (NJ); Remote; USD 124,000 - 193,000; Full time

Job summary

Medasource is seeking a Technical Project Manager to drive an SaMD imaging algorithm program within a regulated QMS. This full-spectrum role focuses on plan ownership, milestone tracking, and cross-functional coordination in a fully remote setting for US time zones.

Target start is before end of 2026 with a Q3 trial launch milestone. You will manage QMS documentation, champion quality compliance, and collaborate with Data Science, IT governance and Quality teams to ensure timely validation and

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.

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

Agile Scrum

Quality mindset

Stakeholder mgmt

Tools

Jira

TrueVault

Asset management

Job description

Medasource is seeking a Technical Project Manager to drive an SaMD imaging algorithm program within a regulated QMS. This full-spectrum role focuses on plan ownership, milestone tracking, and cross-functional coordination in a fully remote setting for US time zones.

Target start is before end of 2026 with a Q3 trial launch milestone. You will manage QMS documentation, champion quality compliance, and collaborate with Data Science, IT governance and Quality teams to ensure timely validation and