Regulatory Affairs Internship – Med Device
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Job Description
Mittal Consulting is a company focused on providing accurate and timely regulatory support for medical device clients globally. They aim to simplify the complex process of obtaining global approvals for novel medical devices by offering expert guidance and a quick turnaround. The company emphasizes challenging the status quo and fostering efficient growth through high levels of customer satisfaction.
This internship is for a Regulatory Affairs Intern working remotely. The intern will play a key role in building regulatory process tools and assisting with a variety of projects. The position offers a great opportunity to gain experience in the regulatory field.
Job Description:
The intern will be responsible for several key tasks, including:
• Gaining a deep understanding of FDA and global regulations for medical devices.
• Assisting in the creation of regulatory training modules using the latest guidance.
• Developing process flows for common FDA submissions.
• Contributing to the compilation of technical files/design dossiers for notified bodies under the EU MDR regulations.
• Assisting in the preparation of various FDA submissions (PMA, 180 DS, RTR, 30 DN, 510(k), and De Novo).
• Ensuring FDA readiness of technical documents through completeness and accuracy checks.
• Performing quality control (QC) reviews of regulatory submission documents, focusing on grammar, spelling, formatting, flow, language clarity, and adherence to regulatory standards.
• Maintaining product submission planners, timelines, and logs.
• Recommending improvements to company procedures to enhance efficiency and adapt to regulatory changes.
