Medical Engineering Innovations, Inc. (MEI), Madison, WI is dedicated to developing medical devices for the advancement of patient care. MEI’s SwiftBlade™ product, currently in development, provides surgical tools for nearly bloodless liver resections and tumor ablations for liver cancer patients. Our goal is to dramatically increase the survival rates for patients while providing cost-effective solutions.
- Direct the Quality and Regulatory Affairs activities of our company to ensure compliance with FDA regulations and ISO standards, including design control, quality assurance, risk management, process control, testing and inspection.
- Develop and maintain company regulatory strategy for medical device compliance and audits.
- Responsible for authoring FDA 510(k) submissions and serve as Regulatory Affairs representative.
- Manage team for the preparation of registration and deliverables for both domestic and international regulatory authorities.
- Responsible for document control and day-to-day quality assurance.
- Work with Product Development team to ensure potential product issues are identified and addressed early in the design process.
- Educate and mentor employees in the Quality Management System.
- Approve suppliers and monitor vendor performance.
- Oversee calibration and testing programs.
- Report to management on quality issues.
- Stay current with changes in regulatory landscape.
- Other duties as assigned.
- Experience in preparing, managing and submitting regulatory submissions.
- Minimum of 5 years’ experience within Quality Assurance and Regulatory affairs.
- Comprehensive knowledge of applicable FDA regulations and experience with EU Directives.
- Bachelor’s degree.
- A proven track record in passing Quality and Regulatory audits is required.
- Meticulous writing and communication skills.
- Above average interpersonal skills required, including conflict resolution.
MEI is an Equal Opportunity/Affirmative Action Employer and embraces diversity in our employee population. We provide equal opportunity to all qualified applicants and employees without regard to race ,color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
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