MIM Software Inc.
Regulatory Affairs Manager
MIM Software Inc., Beachwood, Ohio, United States, 44122
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.
What You'll Do
Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards.Remain current regarding new and existing requirements of medical device manufacturers both nationally and internationally translating them into actionable steps for the organization.Develop and maintain proficient knowledge of MIM’s portfolios, products and classifications, including knowledge of larger features within the software and secondary products.Manage and support the process and preparation of regulatory submissions (e.g., FDA 510k submissions, European (EU) Technical Documentation, etc.)Lead audits by customers and regulatory bodies, including audits by notified bodies (e.g. MDSAP, MDD, EU MDR, UKCA).Oversee MDR (Medical Device Regulation) technical files and change notifications or Design History Files.Review and approve product labeling, promotional materials, and other relevant documentation to ensure compliance with regulatory requirements.Lead and mentor the regulatory team members focusing on learning and development and guiding them through their work and career path.Organize the team's tasks, projects, project involvement, and team resources based on requirements and other company needs.Communicate team member performance, progress, and concerns to individual team members as well as to the VP of Regulatory and Quality, as needed.Regularly set team member goals in order to provide opportunities for the team member's growth.What You'll Need
Bachelor’s Degree in Science, Biotech, Engineering or related field7+ years of experience in regulatory, preferably in the medical device field2+ years of experience managing a teamRAC certification is preferred but not requiredExperience 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 desirableMust be highly organized, possess excellent written and verbal communication skills, and have the ability to multitaskWhat You'll Get
Hybrid work environment so you can work remotely as well as enjoy the officeMIM pays 100% of your insurance monthly costs; including medical, dental, vision, disability, and life insuranceEach employee received a Health Savings Account (HSA) that fully covers the medical deductible20 vacation days and 11 paid company holidays, including the time between Christmas and New YearsA 401(k) with a 4% match that is 100% vested on day oneAnnual Bonus ProgramRelaxed office setting where jeans are the normFree snacks and beverages at the office24 hour access to an in-office fitness center
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What You'll Do
Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards.Remain current regarding new and existing requirements of medical device manufacturers both nationally and internationally translating them into actionable steps for the organization.Develop and maintain proficient knowledge of MIM’s portfolios, products and classifications, including knowledge of larger features within the software and secondary products.Manage and support the process and preparation of regulatory submissions (e.g., FDA 510k submissions, European (EU) Technical Documentation, etc.)Lead audits by customers and regulatory bodies, including audits by notified bodies (e.g. MDSAP, MDD, EU MDR, UKCA).Oversee MDR (Medical Device Regulation) technical files and change notifications or Design History Files.Review and approve product labeling, promotional materials, and other relevant documentation to ensure compliance with regulatory requirements.Lead and mentor the regulatory team members focusing on learning and development and guiding them through their work and career path.Organize the team's tasks, projects, project involvement, and team resources based on requirements and other company needs.Communicate team member performance, progress, and concerns to individual team members as well as to the VP of Regulatory and Quality, as needed.Regularly set team member goals in order to provide opportunities for the team member's growth.What You'll Need
Bachelor’s Degree in Science, Biotech, Engineering or related field7+ years of experience in regulatory, preferably in the medical device field2+ years of experience managing a teamRAC certification is preferred but not requiredExperience 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 desirableMust be highly organized, possess excellent written and verbal communication skills, and have the ability to multitaskWhat You'll Get
Hybrid work environment so you can work remotely as well as enjoy the officeMIM pays 100% of your insurance monthly costs; including medical, dental, vision, disability, and life insuranceEach employee received a Health Savings Account (HSA) that fully covers the medical deductible20 vacation days and 11 paid company holidays, including the time between Christmas and New YearsA 401(k) with a 4% match that is 100% vested on day oneAnnual Bonus ProgramRelaxed office setting where jeans are the normFree snacks and beverages at the office24 hour access to an in-office fitness center
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