Regulatory Affairs Manager

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.

• 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.

• 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

• Hybrid work environment so you can work remotely as well as enjoy the office
• 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