Regulatory Affairs Manager

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MIM Software Inc.

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Medical Devices • Software • Healthcare • Medical Imaging

201 - 500

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