PM- Quality Scrum Master SaMD

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

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

Key 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.

Required 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.

Preferred qualifications

• Direct SaMD, medical device software or MedTech project experience.
• Experience in large, matrixed life sciences or MedTech 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.

Tools and systems

Hands-on use of Jira, TrueVault (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.

What success looks like

• 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.

Technical Project Manager – SaMD / GxP Validation Raritan, New JerseyFor over 16 years, Medasource has established and maintained relationships that are designed to meet your IT staffing needs. Whether it’s contract, contract-to-hire, or permanent placement work, we customise our search based upon your company’s unique initiatives, culture and technologies. With our national team of recruiters placed at 21 major hubs around the nation Medasource finds the people best-suited for your business. When you work with us, we work with you. That’s the Medasource promise.

Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

Benefits & Perks:

Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

Pay Disclaimer:

The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.