Clinical Evaluation & Regulatory Specialist – Medical AI

Location: Göteborg, Sweden; hybrid

Company

hirify.global develops the Dermicus platform and its AI-powered medical device engine for dermatology workflows.

What you will do

• Plan and execute clinical evaluations, clinical performance studies, and post-market clinical follow-up for the Class IIb Dermicus AI Engine.
• Author and maintain the Clinical Evaluation Plan and Report, Clinical Investigation Plan, and PMCF plan and report.
• Own the clinical sections of technical documentation, including intended purpose, indications, target population, clinical claims, and MDR Annex II evidence.
• Translate clinical and regulatory requirements into product requirements with R&D, data science, clinical advisors, and product stakeholders.
• Act as the primary clinical contact for notified-body assessments, audits, and post-market surveillance reviews.
• Coordinate clinical investigators, external experts, and key opinion leaders, and support clinical and regulatory work across the wider hirify.global group.

Requirements

• Clinical, scientific, or allied-health background, such as clinician, nurse, biomedical scientist, or medical physicist, with experience in medical-device clinical evaluation or regulatory affairs.
• Hands-on experience authoring CEPs, CERs, and CIPs under Regulation (EU) 2017/745.
• Strong working knowledge of MDCG 2020-1, MDCG 2019-11, and MEDDEV 2.7/1 revision 4.
• Understanding of medical AI metrics and topics including sensitivity, specificity, AUC, calibration, subgroup performance, dataset composition, and bias.
• Understanding of the EU AI Act for high-risk medical AI and sufficient knowledge of IEC 62304, ISO 14971, and ISO 13485.
• Excellent scientific writing skills in English and a track record of producing clinical evidence packages successfully reviewed by a notified body.

Nice to have

• Experience in dermatology, medical imaging, or another imaging-intensive clinical field.
• Experience using modern AI tools to draft, review, and reason through complex clinical and regulatory material.

Culture & Benefits

• Hybrid work arrangement in Göteborg.
• Cross-disciplinary collaboration across clinical, technical, regulatory, and product functions.
• Opportunity to influence the evidence strategy, product design, and regulatory approach for medical AI used in real-world dermatology workflows.
• Full-time employment in the Mobile Telemedicine department.