Senior RA Engineer

at  Neko Health

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.

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.
  About the Engineering Team

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.