Geared toward regulatory affairs professionals comfortable with EU MDR and FDA submissions for dermatological devices, requiring hands-on collaboration in a fast-moving environment.
Derived from job-description analysis by Serendipath's career intelligence engine.
Original posting from Neko Health via Ashby
Mission
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.
Role Purpose
We are seeking a Regulatory Affairs professional to support our portfolio of dermatological medical devices and software applications. Depending on experience, the position may be hired as either an RA Engineer or RA Engineering Lead, both reporting to the RA Manager. You will work closely with engineering, clinical, product, and project management teams to support regulatory activities across the product lifecycle. The role covers both hardware devices and software as a medical device (SaMD), with a strong focus on EU MDR technical documentation, FDA submissions, post-market activities, and regulatory guidance during development.
This role is suited for someone who is hands-on, comfortable working cross-functionally, and able to apply regulatory requirements pragmatically in a fast-moving development environment.
What You’ll Deliver in the First 6–12 Months
· Establish full ownership of EU MDR Technical Documentation and regulatory dossiers for dermatological hardware and SaMD products in the Skin Program.
· Support or lead at least one FDA premarket submission or CE marking activity, demonstrating end-to-end ownership of the submission process.
· Become the primary regulatory contact for the Skin Program engineering, clinical, and product teams — embedded in design reviews and change control processes from day one.
· Actively contribute to post-market surveillance, PMCF, vigilance, and complaint handling activities, ensuring all products remain in continuous compliance across their lifecycle.
Minimum Qualifications
· BSc or MSc degree within law, medicine, pharmacy, engineering, or another relevant scientific discipline; or equivalent professional experience.
· At least 3 years of professional experience in regulatory affairs or quality management for medical devices.
· Working knowledge of EU Regulation 2017/745 (MDR), FDA 21 CFR (including QSR), UK MDR, ISO 13485, ISO 14971, IEC 60601-1 series, IEC 62304, and other applicable standards.
· Experience with regulatory submissions and direct communication with authorities and Notified Bodies across international markets.
· Excellent analytical skills, able to interpret complex regulatory requirements and provide risk-based, practical recommendations.
· Strong writing and communication skills; able to give clear direction to development teams and engage credibly with external stakeholders.
· Highly self-motivated; able to manage multiple workstreams independently and with minimal supervision.
· Fluent in English (oral and written).
Preferred:
· Experience with active devices, software as a medical device, and dermatology-adjacent medical devices.
· Proficiency in Swedish.
· Comfortable using AI tools in day-to-day work, particularly tools such as Claude and Microsoft Copilot, to support research, drafting, and operational efficiency.
· Experience with tools such as Visual Studio Code and Azure DevOps.
About titles at Neko
We use a simplified internal title framework that prioritises clarity over hierarchy, so internal titles may differ from market‑facing role titles. Scope, impact and level of the role are fully aligned and will be clearly discussed throughout the process.
Hiring Process
Candidates progress from application and structured screening through thoughtfully designed interviews culminating in a formal offer and final pre-employment checks before joining the team.
Equal Opportunity & Inclusion Statement
Neko Health is committed to inclusive hiring and member-first care. We welcome candidates from all backgrounds and encourage you to request reasonable adjustments to support your application.
Source: Neko Health careers (Ashby)