Remote SaMD & AI Medical Device Reviewer (Contractor)

Jobgether; Polska; Remote; PLN 60,000 - 120,000; Full time

Benefits offered by this job

Fully remote

Flexible scheduling

International exposure to regulatory

Job summary

Jobgether, on behalf of a partner company, seeks a Product Reviewer – Contractor based in Poland. You will independently assess medical device software documentation, including SaMD and AI-enabled solutions, for compliance with EU MDR, UK MDR, and IEC 62304.

This fully remote role offers flexible scheduling and the chance to work with manufacturers to address regulatory gaps, ensuring high standards of medical device safety and accelerating certification of advanced healthcare technologies.

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, including IEC 81001-5-1 and MDCG 2019-16.
• Practical understanding of software development fundamentals, including lifecycle processes, verification and validation testing, configuration management, and cybersecurity.
• Demonstrated ability to interpret and apply regulatory requirements when assessing software technical documentation.
• Proven track record of delivering consistent, high-quality technical documentation assessments.
• Experience assessing Software as a Medical Device (SaMD).
• Strong written and verbal communication skills, with the ability to explain technical findings and regulatory requirements clearly and constructively.
• Ability to manage assessments independently and deliver high-quality work with minimal oversight.
• Willingness to adopt established assessment methodologies, workflows, tools, and professional values.
• Preferred: Experience assessing AI and machine learning-enabled medical devices.

Responsibilities

• Independently deliver accurate, consistent, and high-quality technical assessments of medical device software documentation.
• Assess manufacturers' software lifecycle processes and technical documentation for medical device software, including 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.
• Identify, document, communicate, and follow up on technical assessment findings with manufacturers.
• Explain regulatory requirements and assessment findings clearly and constructively, both verbally and in writing.
• Work with manufacturers to clarify technical issues and close out assessment findings.
• Deliver consistent, efficient, and high-quality assessments in accordance with established methodologies, standards, and values.

Job description

Jobgether, on behalf of a partner company, seeks a Product Reviewer – Contractor based in Poland. You will independently assess medical device software documentation, including SaMD and AI-enabled solutions, for compliance with EU MDR, UK MDR, and IEC 62304.

This fully remote role offers flexible scheduling and the chance to work with manufacturers to address regulatory gaps, ensuring high standards of medical device safety and accelerating certification of advanced healthcare technologies.