About the job
Mission
At Neko Health, our mission is to revolutionize healthcare by transitioning from a reactive approach to a proactive one, utilizing state-of-the-art, non-invasive technology alongside clinical expertise to provide early and actionable health insights.
Are you prepared to influence the future of medical technology? We are in search of a Senior Regulatory Affairs Engineer who is enthusiastic about implementing intricate regulatory strategies, has a passion for working with innovative medical devices, and excels in a dynamic, collaborative, and distributed environment.
We seek candidates with extensive experience in managing active medical devices and software as a medical device throughout their entire product lifecycle.
Your Responsibilities
Regulatory Leadership: Ensure our innovative medical devices comply with global standards and regulations, aligning regulatory strategies from R&D through to market entry and post-market activities.
Product Development Support: Provide guidance on regulatory strategy during the product lifecycle, impacting design, risk management, supplier selection, and labeling.
Regulatory Documentation Management: Create and maintain essential regulatory documentation, including Design History Files (DHF), Technical Documentation, Device Master Records (DMR), and Device History Records (DHR).
Regulatory Submissions Management: Prepare, review, and submit documentation for EU MDR, FDA, and other international markets.
Product Safety Monitoring: Engage in post-market surveillance, CAPA, and complaint management activities.
Engagement with Regulatory Authorities: Facilitate communication with regulatory bodies, managing certification projects and vigilance activities to ensure timely compliance and reporting.
Empowerment of Teams: Assist process owners and product teams in integrating regulatory requirements within our Quality Management System and deliver training on compliance and regulatory matters.
Regulatory Trend Monitoring: Stay updated on regulatory trends, providing insights to keep Neko Health at the forefront of compliance.
Your Qualifications
Significant experience in regulatory affairs within the medical device or healthcare technology sector.
Deep knowledge of global regulatory standards, including EU MDR and FDA requirements.
Strong communication, analytical, and problem-solving skills.
Ability to thrive in a fast-paced, collaborative environment.