MIM Software Inc.
MIM Software Inc. is a vendor-neutral imaging software company that aims to standardize workflows in healthcare settings and simplify clinical processes. Their solutions are widely used in radiation oncology, radiology, nuclear medicine, and theranostics to provide more precise and personalized patient care. MIM Software offers a suite of products that include tools for plan preparation, AI auto-contouring, and treatment planning. With a focus on remote access and enterprise solutions, MIM Software serves over 3,300 global healthcare organizations, including top hospitals and research institutions. MIM is dedicated to improving patient care by enabling more confident decisions in less time, and they have recently gained FDA clearance for innovative tools like Monte Carlo Dosimetry and a Centiloid Scaling Tool.
Medical Devices • Software • Healthcare • Medical Imaging
Regulatory Affairs Manager
November 13, 2024
MIM Software Inc.
MIM Software Inc. is a vendor-neutral imaging software company that aims to standardize workflows in healthcare settings and simplify clinical processes. Their solutions are widely used in radiation oncology, radiology, nuclear medicine, and theranostics to provide more precise and personalized patient care. MIM Software offers a suite of products that include tools for plan preparation, AI auto-contouring, and treatment planning. With a focus on remote access and enterprise solutions, MIM Software serves over 3,300 global healthcare organizations, including top hospitals and research institutions. MIM is dedicated to improving patient care by enabling more confident decisions in less time, and they have recently gained FDA clearance for innovative tools like Monte Carlo Dosimetry and a Centiloid Scaling Tool.
Medical Devices • Software • Healthcare • Medical Imaging
📋 Description
•The Regulatory Affairs Manager leads the international regulatory team working cross-functionally with a team on product changes, regulatory notification, approval requirements, and solving regulatory issues. •You will work cross-functionally both internally and with partners to execute the regulatory strategy to achieve worldwide market access and compliance.
🎯 Requirements
•Bachelor’s Degree in Science, Biotech, Engineering or related field •7+ years of experience in regulatory, preferably in the medical device field •2+ years of experience managing a team •RAC certification is preferred but not required •Experience in managing and/or participating in regulatory submissions with a strong understanding of both domestic and international regulations (FDA, MDR, ETC.) •Experience with Software as a Medical Device (SaMD) is highly desirable •Must be highly organized, possess excellent written and verbal communication skills, and have the ability to multitask
🏖️ Benefits
•MIM pays 100% of your insurance monthly costs; including medical, dental, vision, disability, and life insurance •Each employee received a Health Savings Account (HSA) that fully covers the medical deductible •20 vacation days and 11 paid company holidays, including the time between Christmas and New Years •A 401(k) with a 4% match that is 100% vested on day one •Annual Bonus Program •Relaxed office setting where jeans are the norm •Free snacks and beverages at the office •24 hour access to an in-office fitness center
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