Sweden Job Openings
Neko Health
Senior RA Engineer
FULL TIME
August 27, 2024
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 ensuringthat 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 fromcollaboratingwith 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 surveillanceto 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 submissionsfor 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 productlifecycle.
Distributed and Remote First
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
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.
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