Regulatory Affairs Engineer, Post-Market Surveillance

The role

You will run and maintain the post-market surveillance process across the device portfolio. You will implement the PMS SOP, produce periodic reports, and contribute to regulatory activities throughout the device lifecycle.

What you will do

• Run and maintain the post-market surveillance process across the device portfolio
• Put the PMS SOP into practice and propose updates
• Produce periodic post-market trend reporting and post-market literature searches
• Prepare post-market sections of technical documentation and periodic reports for Notified Bodies
• Support regulatory owners of individual devices on post-market questions

Required qualifications

• 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
• Medical device experience
• Familiarity in MDCG guidances and post-market obligations specific to medical devices
• 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
• 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

Nice to have

• Experience automating or streamlining regulatory workflows, including light scripting
• Experience with Visual Studio Code and Azure DevOps

Benefits

• Competitive salary and benefits package

About the company

Neko aims to make data-driven, preventative care accessible through proprietary technology and direct clinical care. The company designs and manufactures its own devices.