Senior RA Engineer

Neko Health is a Swedish health-tech company co-founded in 2018 by Hjalmar Nilsonne and Daniel Ek. Our vision is to create a healthcare system that can help people stay healthy through preventive measures and early detection. Neko has developed a new medical scanning technology concept to make it possible to do broad and non-invasive health data collection that is both convenient and affordable for the public. This requires completely reimagining the healthcare experience and incorporating the latest advances in sensors and AI. We are a remote first company, but the company is based in Stockholm and has almost 100 employees across Europe.

About the Role:

We are seeking a skilled and experienced Senior RA Engineer to join our dynamic and distributed team. As a Senior RA Engineer at Neko, you will play a crucial role in ensuring that our medical devices are developed, manufactured, distributed, and maintained in compliance with relevant regulations and standards.

In this role, you will work on diverse tasks with different stakeholders, ranging from collaborating with and providing regulatory guidance to cross-functional teams throughout the product lifecycle to the preparation and submission of regulatory filings. You will plan, lead, and execute regulatory activities and decisions to ensure proper documentation and tracking.

Responsibilities:

• Collaborate with and provide regulatory guidance to cross-functional teams during product development, manufacturing, and post-market surveillance to ensure compliance with applicable regulations and standards (e.g., FDA, EU MDR, UK MDR, ISO 13485).
• Provide regulatory input during design reviews, risk assessments, and change management processes.
• Develop and maintain regulatory documentation, including Design History File (DHF), Technical Documentation, and Risk Management Files as well as Device Master Record (DMR) and Device History Records (DHR).
• Prepare, review, and submit regulatory submissions for different markets.
• Respond to inquiries and requests from regulatory authorities and agencies and manage communication for specific questions.
• Plan, lead, and execute regulatory activities and decisions to ensure proper documentation and tracking.
• Stay current with changes in global regulatory requirements and communicate these changes to relevant stakeholders.

Requirements:

• Established commercial experience in Regulatory Affairs roles within the Medical Device industry.
• Deep understanding of regulatory compliance principles and activities.
• Deep knowledge of FDA regulations, EU MDR, UK MDR, ISO 13485 and other relevant regulatory standards.
• Extensive experience with regulatory submissions for different international markets.
• Background in medical device development in general and agile software development in particular.
• Effective communication skills (written and verbal) and teamwork abilities, essential for our remote-first environment.
• Exceptional analytical and problem-solving skills.
• A product mindset, with a solid understanding of user needs and product lifecycle.

About the Engineering Team

Distributed and Remote First

We are 40 full-time engineers at the company, working from Berlin, Chamonix, Hamburg, Lisbon, Marseille, Vilnius, and Stockholm, spanning diverse disciplines such as Hardware Engineering, Firmware Development, Electrical Design, Algorithm Development, Machine Learning Development, Optronics Research, Frontend Development and more.

Our headquarters and our hardware development team are in Stockholm, Sweden.

We are a Remote First company; however, it is of course much easier to work remotely as a software engineer than a hardware or firmware engineer (since they require access to hardware or devices occasionally). Software engineers based in Stockholm work maybe one day a week or one day every two weeks from the office.

We meet a couple of times per year to get to know each other and have fun.

Organization and Way of Working

The engineering team is divided into smaller cross-functional project teams that each focus on a specific goal or target, where some groups are long-lived, and some are short-lived, depending on how big the goal or deliverable is. We strive to create groups which are cross-functional and able to complete their goals without dependence on other teams, even though this is of course not always possible.

Groups track goals on a yearly and quarterly basis with goal follow-up across the entire engineering organization on a bi-weekly basis. Most groups do internal planning on a bi-weekly basis, but in the end, it's up to the group to decide how they want to work.

We have, however, mandated that all groups must present their progress or failures or hacks at our bi-weekly engineering demo, a fun meeting/presentation where we talk about everything from short-circuiting power-modules, how hard it is to calibrate cameras or align polygons in space, to neat new command line tools for operations, a new auth mechanism in the backend, a cool new way to visualize health data or a new feature which helps our doctors be more productive.

We have a flexible workplace that focuses on work/life balance, and we strongly believe in our mission but do not think that achieving it requires sacrificing everything else.