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Neko Health is seeking a Regulatory Affairs Engineer to lead post-market surveillance (PMS) operations across its medical device portfolio. The company is redefining preventative healthcare through proprietary technology that delivers personalized health insights in a single, non-invasive visit.
In this cross-programme role reporting to the RA Engineering Lead, you will operate and continuously improve Neko's established post-market surveillance system, ensuring consistent application across all devices as the portfolio expands. You will have significant autonomy in determining how work is carried out while receiving overall direction from your manager.
Key responsibilities include:
- Running and maintaining the PMS process across the device portfolio with consistency
- Implementing and updating the PMS Standard Operating Procedure (SOP) as the process matures
- Producing periodic post-market trend reports and literature searches with repeatable methodologies
- Preparing post-market sections of technical documentation and periodic reports for Notified Bodies
- Supporting regulatory owners of individual devices on post-market questions
- Collaborating across regulatory, quality, clinical, and engineering teams
You will thrive in this role if you prefer creating repeatable, efficient processes over individual task work; collaborate easily across functions; understand post-market obligations across multiple risk classes; and enjoy optimizing and streamlining regulatory workflows. The role offers cross-programme visibility into the entire device portfolio rather than a single device, direct guidance from an experienced RA Engineering Lead with room to grow, and close proximity to engineering, clinical, quality, and product teams. Because Neko designs and manufactures its own devices, field feedback reaches you directly and informs product iteration.
REQUIREMENTS:
- BSc or MSc in engineering, medicine, pharmacy, law, or another relevant scientific discipline, or equivalent professional experience
- At least 3 years in regulatory affairs or quality for medical devices, with meaningful time spent on post-market activities (3–5 years is the target range)
- Medical device experience with familiarity in MDCG guidances and post-market obligations
- Working knowledge of EU Regulation 2017/745 (MDR) post-market requirements, applicable MDCG guidances, ISO 13485, and ISO 14971
- Experience contributing to periodic post-market reporting for a Notified Body
- Excellent analytical and writing skills (output subject to audit)
- Self-motivated and able to run a cross-programme workstream efficiently
- Fluent in English (oral and written)
- Comfortable using AI tools such as Claude for research, drafting, and operational efficiency
- Advantageous: experience automating or streamlining regulatory workflows including light scripting; experience with Visual Studio Code and Azure DevOps
