Remote Medical Device Software Assessor

Jobgether; United States; Remote; USD 83,000 - 131,000; Full time

Benefits offered by this job

Fully remote

Flexible scheduling

Work on AI-enabled device projects

Job summary

Jobgether seeks an experienced medical device software reviewer to independently deliver accurate, high-quality technical assessments of regulatory documentation for SaMD and AI-enabled devices.

You will evaluate lifecycle processes, verify compliance with EU/UK MDR, IEC 62304, ISO 14971, and cybersecurity standards, and communicate findings clearly to manufacturers. This fully remote contractor role offers flexible scheduling and international exposure.

Qualifications

• Bachelor's degree or higher in software/engineering.
• Minimum 4 years in medical device or safety-critical industries.
• At least 2 years designing or testing safety-critical software.
• Experience as a reviewer for a notified body or UK approved body.
• Familiarity with IEC 62304, IEC 82304-1, ISO 14971 and related cybersec needs.
• Ability to interpret regulatory requirements and communicate findings clearly.

Responsibilities

• Independently deliver accurate, high-quality technical assessments of software documentation.
• Evaluate lifecycle processes and regulatory compliance for SaMD and AI devices.
• Identify, document, and follow up on assessment findings with manufacturers.
• Explain regulatory requirements clearly, verbally and in writing.
• Work with manufacturers to clarify issues and close out findings.
• Adopt established methodologies and workflows for consistency.

Skills

Regulatory knowledge

Independent work

Technical assessment

Medical device software

Education

Bachelor's degree in Software Engineering

Electrical/Electronic Engineering

Job description

Jobgether seeks an experienced medical device software reviewer to independently deliver accurate, high-quality technical assessments of regulatory documentation for SaMD and AI-enabled devices.

You will evaluate lifecycle processes, verify compliance with EU/UK MDR, IEC 62304, ISO 14971, and cybersecurity standards, and communicate findings clearly to manufacturers. This fully remote contractor role offers flexible scheduling and international exposure.