Clinical Evaluation & Regulatory Specialist – Medical AI

Clinical Evaluation & Regulatory Specialist – Medical AI Help bring trusted medical AI into clinical practice. Lead the evidence strategy for Omda Dermicus AI Engine and shape safer, smarter dermatology workflows that improve care across Europe. Purpose of the role Lead the clinical evaluation and clinical performance activities for the Omda Dermicus AI Engine, a Class IIb medical device under MDR Rule 11 and an AI-powered accessory to the Dermicus platform. You will define, setup and lead clinical studies and clinical evaluation for Dermicus AI Engine, work closely with R&D, our AI Engine data scientist and clinical advisors to generate, document and maintain the clinical evidence required for CE marking and ongoing post-market surveillance. As capacity allows, you will also contribute clinical, regulatory and product expertise across the wider Omda group. Key responsibilities Clinical evaluation and performance studies This is the primary focus of the role. Plan and execute clinical evaluations, clinical performance studies and post-market clinical follow-up activities for the AI Engine. Author and maintain the Clinical Evaluation Plan and Report (CEP/CER), Clinical Investigation Plan (CIP), and PMCF plan and report. Ensure that clinical activities comply with the EU MDR, relevant MDCG guidance and applicable requirements for AI-based medical device software. Clinical content of the technical documentation Own the clinical sections of the AI Engine technical documentation. Define and maintain the intended purpose, indications, target population and clinical claims. Compile and maintain the clinical evidence required under MDR Annex II. Provide clinical input to the General Safety and Performance Requirements, risk-management file, post-market surveillance documentation and related quality records. Clinical and product collaboration Translate clinical needs and evidence requirements into clear product requirements in collaboration with R&D and the AI Engine data scientist. Contribute to decisions concerning intended use, target populations, dataset composition and representativeness, clinical claims and human oversight. Help ensure that model performance, user experience and clinical workflows are aligned with patient safety and regulatory requirements. Notified body and external collaboration Act as the primary clinical contact for the notified body during conformity assessment, audits and post-market surveillance reviews. Coordinate clinical investigators, external clinical experts and key opinion leaders. Present and defend the clinical evidence clearly and confidently during external reviews. Wider portfolio support Provide clinical, regulatory and product-management input to other Omda business units when the AI Engine workload permits. About you You have a clinical, scientific or allied-health background—for example, as a clinician, nurse, biomedical scientist or medical physicist—and have moved into clinical evaluation or regulatory affairs for medical devices. Experience in dermatology, medical imaging or another imaging-intensive clinical field is an advantage, but not essential. We are looking for someone who: Has hands-on experience authoring CEPs, CERs and CIPs under Regulation (EU) 2017/745. Has a strong working knowledge of MDCG 2020-1, MDCG 2019-11 and MEDDEV 2.7/1 rev. 4. Understands medical AI and can engage confidently in discussions about sensitivity, specificity, AUC, calibration, subgroup performance, dataset composition and bias. Understands the implications of the EU AI Act for high-risk medical AI. Has sufficient knowledge of IEC 62304, ISO 14971 and ISO 13485 to ensure that clinical evidence integrates effectively with software-development, risk-management and quality documentation. Uses modern AI tools as a natural part of their work—for example, to draft, review and reason through complex clinical and regulatory material efficiently and responsibly. Is an excellent scientific writer in English. Has a demonstrable track record of producing clinical evidence packages that have been successfully reviewed by a notified body. Is comfortable working across clinical, technical, regulatory and product disciplines. Why this role matters This role will be central to bringing clinically meaningful and responsibly developed medical AI into real-world dermatology workflows. You will have a direct influence on the evidence, product design and regulatory strategy behind the Dermicus AI Engine—and ultimately on how the technology supports clinicians and patients. Department Mobile Telemedicine Locations Göteborg Remote status Hybrid Employment type Full-time Göteborg About Omda Omda is the leading provider of specialised software for healthcare in the Nordics with a growing presence in Europe, North America and the Pacific region. The company serves more than 500 customers in 27 countries and employs almost 300 dedicated specialists. Our highly specialised healthcare solutions empower medical professionals and emergency responders, enabling them to know more and work smarter. With a focus on user-centric design, value-driven development and close working relationships with customers, Omda delivers solutions that enhance patient safety and improve healthcare outcomes. Founded in 2005 Co-workers Around 300