Senior Regulatory Affairs Engineer (TCI)
Full-timeJob Overview
Are you ready to shape the future of medical technology? Neko Health is seeking a Senior Regulatory Affairs Engineerwho’s passionate about tackling complex regulatory strategies, enjoys working with cutting-edge medical devices, and thrives in a fast-paced, collaborativeand 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.
Are you ready to shape the future of medical technology? Neko Health is seeking a Senior Regulatory Affairs Engineerwho’s passionate about tackling complex regulatory strategies, enjoys working with cutting-edge medical devices, and thrives in a fast-paced, collaborativeand 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.
What You’ll Do
- 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 withRegulatory 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.
What You Bring
- Education: BSc or MSc in law, medicine, pharmacy, engineering, or a related field.
- Experience: 4–5+ 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.