Ensure regulatory compliance for cutting-edge medical devices through strategic guidance, documentation management, and collaboration with regulatory bodies.
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.
Please mention you found this job on AI Jobs. It helps us get more startups to hire on our site. Thanks and good luck!
Get hired quicker
Be the first to apply. Receive an email whenever similar jobs are posted.
Ace your job interview
Understand the required skills and qualifications, anticipate the questions you may be asked, and study well-prepared answers using our sample responses.
