Neko Health
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.
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 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.
What You’ll Bring
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.
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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 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.
What You’ll Bring
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.
#J-18808-Ljbffr