Remote SaMD & AI Medical Device Reviewer

Jobgether; Ireland; Remote; EUR 96,000 - 138,000; Full time

Benefits offered by this job

Fully remote

Flexible scheduling

Independent work

Job summary

Jobgether is seeking a Product Reviewer to independently assess medical device software documentation, including SaMD and AI-enabled devices, against EU MDR/UK MDR and IEC standards. This fully remote contractor role emphasizes independent judgment, clear communication, and adherence to established assessment workflows.

Responsibilities include evaluating lifecycle processes, documenting findings, and guiding manufacturers to address regulatory gaps.

Qualifications

• Bachelor's degree or higher in Software Engineering, Computer Science, Electrical or Electronic Engineering, or a closely related discipline.
• At least 4 years of professional experience in the medical device industry or another safety-critical sector.
• At least 2 years of experience designing, developing, or testing safety-critical software.
• Experience as a Product Reviewer or technical documentation assessor for a notified body or UK approved body, covering software devices such as MDA 0315 or MDS 1011.
• Working knowledge of IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1, and medical device cybersecurity requirements (IEC 81001-5-1, MDCG 2019-16).
• Practical understanding of software development fundamentals, including lifecycle processes, verification and validation testing, configuration management, and cybersecurity.
• Ability to interpret regulatory requirements when assessing software documentation.
• Proven track record of delivering high-quality assessments.
• Experience assessing SaMD.
• Strong written and verbal communication skills for clear regulatory explanations.
• Ability to manage assessments independently with minimal oversight.
• Willingness to adopt established methodologies and workflows.

Responsibilities

• Independently deliver accurate, high-quality technical assessments of medical device software documentation.
• Evaluate compliance with EU MDR, UK MDR, IEC 62304, IEC 82304-1, IEC 62366-1, and IEC 81001-5-1.
• Review software development and lifecycle documentation to verify regulatory and 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 clarify issues and close out findings.
• Deliver high-quality assessments following established methodologies and values.
• Apply independent judgment with minimal supervision.
• Adopt established assessment workflows to ensure consistency and quality across reviews.

Skills

Regulatory know-how

SaMD experience

Lifecycle processes

Documentation review

IEC 62304

IEC 82304-1

Communication skills

Independent work

AI/ML familiarity

Education

Bachelor's degree in Engineering or CS

Job description

Jobgether is seeking a Product Reviewer to independently assess medical device software documentation, including SaMD and AI-enabled devices, against EU MDR/UK MDR and IEC standards. This fully remote contractor role emphasizes independent judgment, clear communication, and adherence to established assessment workflows.

Responsibilities include evaluating lifecycle processes, documenting findings, and guiding manufacturers to address regulatory gaps.