ШвецияRegulatory Affairs Engineering Lead, Clinical Evaluation
3 нед. назад
ШвецияLeadHybrid
iso 14155clinical evaluationregulatory submissionsclinical studies
Lead clinical evaluation and regulatory affairs for medical devices to support regulatory submissions.
О компании
- Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission: make data-driven, preventative care accessible to more people, before symptoms appear. In a single, non-invasive visit under an hour, proprietary technology and direct clinical care combine to deliver personalised, actionable insights. It's a team that thinks in 10x, not 10%. Every role here plays a part in building a world where prevention is the norm, and where your work genuinely helps people live longer, healthier lives.
Обязанности
- We're looking for a regulatory affairs engineer to own the clinical side of Neko's regulatory work. You'd write the clinical evaluation plans and reports, and the clinical documentation behind our submissions to the FDA, the EU and the UK.
- Neko generates its own clinical evidence, so this is authored work. You'd plan and support clinical studies and investigations under ISO 14155, appraise the literature and the clinical data behind each claim, and keep the clinical evaluation current as the devices change.
- It's hands-on and it runs across both hardware and software, working closely with the engineering, clinical and quality teams. You'd join a small regulatory team where the other engineers come from hardware and software backgrounds, which is why this role leans clinical.
- 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 the 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
Требования
- 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
Будет плюсом
- A research or clinical science background
- Post-market clinical follow-up and PMCF plans
- Wearables, imaging or screening devices, where the company generated its own clinical evidence
- ISO 14971 risk management and IEC 62366-1 usability applied in product development
- ISO 13485 quality management systems, and embedding regulatory requirements into QMS processes
- Mentoring colleagues on regulatory or clinical evaluation topics
- Experience inside a fast-growing health technology company
- Fluent Swedish
Условия
- The clinical evidence behind a Neko scan is generated here, so the documents you write are the argument for what the product is allowed to tell someone about their own health. You'd own that argument across the FDA, the EU and the UK.
- The regulatory team is small and sits next to the engineers building the devices, so a question about what the evidence can support gets answered in a conversation. You'd be the first person here whose weight is on the clinical and study side.