Regulatory Affairs Engineering Lead, Clinical Evaluation
Hybrid (Stockholm), Hybrid (Berlin), Hybrid (London)Full-timePosted 4w ago
About the role
Regulatory affairs engineer responsible for the clinical side of regulatory work, authoring clinical evaluation plans/reports and supporting submissions to FDA, EU, and UK. Plans and supports clinical studies under ISO 14155, maintains clinical evaluation with device changes, and collaborates with hardware/software teams in a hybrid environment.
Responsibilities
- Write clinical evaluation plans and clinical evaluation reports under EU MDR Annexes XIV and XV, including the literature review and the appraisal of clinical data behind them
- Own the regulatory side of clinical studies and clinical investigations, from study design input through to clinical investigation submissions, under ISO 14155, UK MDR 2002 and FDA 21 CFR
- Build the regulatory strategy for clinical evidence across EU MDR, FDA and UK MDR, and turn it into a prioritised roadmap the engineering and product teams can work to
- Prepare submissions and maintain the clinical sections of technical files, pulling together engineering, clinical and quality input for notified body or agency review
- Give regulatory guidance to hardware and software teams on IEC 62304, IEC 60601-1 and IEC 62366-1, so those requirements are part of how the devices get built
- Assess the regulatory and clinical impact of device changes, hardware and software, and support change control
- Own post-market surveillance and post-market clinical follow-up from the clinical evidence side, including regulatory change monitoring and incident reporting
- Design and deliver regulatory and clinical evaluation training for process owners and product teams
- Support internal and external audits, including notified body and agency interactions
Qualifications
- You have personally authored clinical evaluation plans and reports, clinical investigation plans, or clinical study protocols for medical devices
- Medical device regulatory experience under EU MDR, and under at least one of FDA 21 CFR or UK MDR 2002
- Clinical evaluation methodology: MEDDEV 2.7/1 Rev 4 and current MDCG guidance
- Clinical investigation requirements under ISO 14155, applied to real studies
- Hands-on submission preparation, with the clinical documentation as your part of it
- Comfortable across hardware and software regulatory requirements, including IEC 62304, IEC 60601-1 and IEC 62366-1, and able to turn them into guidance an engineer can act on
- A risk-based, proportionate approach to compliance, and the judgement to tell what needs regulating from what doesn't
- Fluent English
- BSc or MSc in engineering, or in another relevant scientific discipline
Skills
Required:Clinical evaluation planning and reportingRegulatory submissions (EU MDR, FDA 21 CFR, UK MDR 2002)ISO 14155IEC 62304/60601-1/62366-1Regulatory strategy & roadmap
Last updated Oct 23, 2026. Interested? Apply on the company site.
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