Remote Medical Device Software Reviewer (SaMD/AI)

Jobgether; Australia; Remote; AUD 96,000 - 165,000; Part time

Benefits offered by this job

Fully remote contractor position

Flexible scheduling depending on need

Exposure to international regulatory -

Opportunity to work on AI-enabled SaMD

Job summary

Jobgether on behalf of a partner company is seeking a Product Reviewer – Contractor based in Australia. You will independently assess medical device software, SaMD, and AI-enabled solutions, ensuring regulatory, technical and safety requirements are met across lifecycle documentation.

Responsibilities include evaluating compliance with EU MDR, UK MDR, IEC 62304, IEC 82304-1 and related standards, and communicating findings to manufacturers.

Qualifications

• Bachelor's degree in software/engineering or closely related field.
• At least 4 years in medical device industry or safety-critical sector.
• At least 2 years designing, developing, or testing safety-critical software.
• Experience as Product Reviewer or documentation assessor for a notified/approved body.
• Working knowledge of IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1, IEC 81001-5-1, and MDCG guidance.
• Strong ability to interpret regulatory requirements and apply them to software documentation.
• Proven track record delivering high-quality technical documentation assessments.
• Experience with Software as a Medical Device (SaMD).
• Strong written and verbal communication skills.

Responsibilities

• Assess manufacturers' software lifecycle processes and technical documentation for medical device software, SaMD and AI-enabled devices.
• Evaluate compliance with EU MDR, UK MDR, IEC 62304, IEC 82304-1, IEC 62366-1, and IEC 81001-5-1.
• Review software development/lifecycle docs to verify regulatory/technical requirements are met.
• Identify and communicate technical assessment findings with manufacturers.
• Explain regulatory requirements clearly, both verbally and in writing.
• Work with manufacturers to address technical issues and close out findings.
• Deliver high-quality assessments following established methodologies and workflows.
• Apply independent judgment with minimal supervision.
• Adopt established assessment tools and workflows for consistency.

Skills

Software lifecycle assessment

Regulatory interpretation

Technical documentation audits

SaMD experience

AI in medical devices

Independent reviewer

Regulatory communication

Education

Bachelor's degree in Software Engineering / Computer Science / Electrical or Electronic Engineering

Tools

IEC 62304

IEC 82304-1

ISO 14971

IEC 62366-1

IEC 81001-5-1

MDCG guidance (2019-16/2019-11/2020-1)

Job description

Jobgether on behalf of a partner company is seeking a Product Reviewer – Contractor based in Australia. You will independently assess medical device software, SaMD, and AI-enabled solutions, ensuring regulatory, technical and safety requirements are met across lifecycle documentation.

Responsibilities include evaluating compliance with EU MDR, UK MDR, IEC 62304, IEC 82304-1 and related standards, and communicating findings to manufacturers.