ШвецияRegulatory Affairs Engineer, Post-Market Surveillance
3 нед. назад
ШвецияHybrid
post-market surveillanceregulatory affairssop implementationreporting
Responsible for managing post-market surveillance and regulatory affairs to ensure compliance and continuous improvement across medical device portfolio.
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 are looking for a regulatory affairs engineer to strengthen how Neko runs post-market surveillance across its device portfolio.
- This cross-programme role reports to the RA Engineering Lead. Neko already has a post-market surveillance system in place, and you will be responsible for operating it, ensuring it is applied consistently across all devices, and driving its continuous improvement. Your duties will include implementing the PMS SOP, producing periodic reports, and transforming an established process into one that is increasingly systematic and efficient as the portfolio expands. While the RA Engineering Lead provides overall direction and supports regulatory decisions, you will have autonomy in determining how the work is carried out.
- In addition to post-market surveillance, you will serve as a regulatory affairs engineer for our products, contributing to regulatory activities throughout the device lifecycle alongside the rest of the RA team. Depending on your experience, the position may be offered as either Regulatory Affairs Engineer or RA Engineering Lead.
- You are likely to thrive in this role if you:
- Are knowledgeable about post-market guidance and understand the current best practices for PMS activities, going beyond just regulatory requirements.
- Have hands-on experience with devices that have been available on the market for several years.
- Prefer creating repeatable processes and running them efficiently, rather than working on tasks individually.
- Collaborate easily across functions—post-market surveillance requires working with regulatory, quality, clinical, and engineering teams.
- Have experience managing post-market obligations across multiple risk classes and understand how these requirements differ.
- Enjoy optimizing work processes, especially streamlining and accelerating repetitive regulatory tasks.
- Excel under a manager who provides direction but allows you the autonomy to choose how to accomplish your work.
Условия
- Cross-programme scope from day one, across the whole device portfolio rather than a single programme.
- Direct guidance from an experienced RA Engineering Lead, and room to grow into wider ownership.
- Close proximity to engineering, clinical, quality and product teams in a company that designs and builds its own devices.
- A small, experienced regulatory team where your judgement carries weight and your contributions are visible.
- Competitive salary and benefits package.
Другое
- Run and maintain the post-market surveillance process across the device portfolio, applying it consistently from programme to programme.
- Put the PMS SOP into practice, keep it current, and propose updates as the process matures.
- Produce the periodic post-market trend reporting and the post-market literature searches, and establish a repeatable method for both.
- Prepare the post-market sections of technical documentation and the periodic reports delivered to Notified Bodies.
- Support the regulatory owners of individual devices on post-market questions, and become the reliable
- 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 a meaningful part of that time spent on post-market activities (three to five years is the target)
- Medical device experience, with 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, as much of the role's output is 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
- Experience automating or streamlining regulatory workflows, including light scripting, is an advantage
- Experience with Visual Studio Code and Azure DevOps is an advantage
- Post-market surveillance at Neko is a process you get to shape while you run it, not a fixed machine you feed. Because the role is cross-programme, you see the whole portfolio rather than one device. And because Neko designs and manufactures its own devices, what comes back from the field reaches you directly and feeds into the next version of the product.