Senior Regulatory Affairs Engineer; TCI

Senior Regulatory Affairs Engineer (TCI)

Are you ready to shape the future of medical technology? Neko Health is seeking a Senior Regulatory Affairs Engineer who’s passionate about tackling complex regulatory strategies, enjoys working with cutting‑edge medical devices, and thrives in a fast‑paced, collaborative and distributed environment.

We are looking for you that have extensive experience from working with active medical devices and software as a medical device throughout the product lifecycle.

• Drive Regulatory Excellence :
  Ensure our cutting‑edge medical devices meet global standards and regulations as well as align with regulatory strategies from research and development to market launch and post‑market.
• Support Product Development :
  Advise on regulatory strategy throughout the product lifecycle, influencing design, risk management, supplier selection, and device labeling.
• Maintain Regulatory Documentation :
  Develop and maintain regulatory documentation, including Design History File (DHF), Technical Documentation, as well as Device Master Record (DMR) and Device History Records (DHR).
• Own Regulatory Submissions :
  Prepare, review, and submit documentation for EU MDR, FDA, and other international markets.
• Monitor Product Safety :
  Participate in post‑market surveillance, CAPA, and complaint management activities.
• Interact with Regulatory Bodies :
  Coordinate communications with regulatory bodies and drive certification projects and vigilance activities, ensuring timely reporting and compliance.
• Empower Process Owners and Teams :
  Guide process owners and product teams to integrate regulatory requirements into our Quality Management System and deliver impactful training on compliance and regulatory topics.
• Stay Ahead :
  Monitor regulatory trends and provide intelligence to keep Neko Health at the forefront of compliance.

• Education : BSc or MSc in law, medicine, pharmacy, engineering, or a related field.
• Experience : 45+ years in regulatory affairs or quality management for active medical devices and software as a medical device.
• Expertise :
  Deep knowledge of EU MDR, FDA CFR (Title 21 Subchapter H), UK MDR, ISO 13485, IEC 60601‑1, IEC 62304, ISO 14971, and more.
• Skills :
  Analytical, detail‑oriented, and able to interpret complex regulations to provide risk‑based recommendations.
• Communication :
  Excellent interpersonal and writing skills; able to engage and inspire both internal teams and external stakeholders.
• Mindset :
  Self‑motivated, independent, and ready to take ownership in a dynamic, quality‑focused environment.
• Languages :
  Fluent English required;
  Swedish proficiency is a plus.