Regulatory Affairs Engineer (Medical Devices)

Location: Hybrid in Stockholm, Berlin, or London

Company

hirify.global develops non-invasive, data-driven preventative healthcare technology combining proprietary devices with direct clinical care.

What you will do

• Author clinical evaluation plans and reports, including literature reviews and clinical data appraisal under EU MDR Annexes XIV and XV.
• Lead the regulatory aspects of clinical studies and investigations under ISO 14155, UK MDR 2002, and FDA 21 CFR.
• Build regulatory strategies and prioritised roadmaps for clinical evidence across the EU, US, and UK.
• Prepare submissions and maintain clinical sections of technical files with engineering, clinical, and quality input.
• Guide hardware and software teams on IEC 62304, IEC 60601-1, and IEC 62366-1, including device-change assessments and change control.
• Own the clinical evidence aspects of post-market surveillance, post-market clinical follow-up, regulatory change monitoring, incident reporting, training, and audit support.

Requirements

• Personally authored clinical evaluation plans and reports, clinical investigation plans, or medical-device clinical study protocols.
• Medical-device regulatory experience under EU MDR and at least one of FDA 21 CFR or UK MDR 2002.
• Practical knowledge of MEDDEV 2.7/1 Rev 4, current MDCG guidance, and ISO 14155 applied to real studies.
• Hands-on submission preparation and the ability to apply hardware and software requirements across IEC 62304, IEC 60601-1, and IEC 62366-1.
• Risk-based compliance judgement, plus a BSc or MSc in engineering or another relevant scientific discipline.
• Fluent English required.

Nice to have

• Research or clinical science background and experience with PMCF plans.
• Experience with wearables, imaging, or screening devices generating in-house clinical evidence.
• ISO 14971 risk management, IEC 62366-1 usability, or ISO 13485 quality management systems experience.
• Mentoring experience or experience in a fast-growing health technology company.
• Fluent Swedish.

Culture & Benefits

• Work in a small regulatory team alongside hardware and software engineers.
• Collaborate closely with engineering, clinical, and quality teams.
• Contribute to preventative healthcare technology intended to make data-driven care more accessible.
• Own clinical evidence supporting product claims across the EU, FDA, and UK regulatory frameworks.