Regulatory Affairs Specialist II

Eden Prairie, MN                ·             Full time

As an innovator of the next generation of neurointerventional medical devices, MIVI Neuroscience employees are passionate about making a difference in patients’ lives and we are looking for like-minded individuals to join our team.  If you are a highly motivated and self-driven individual looking to use your experience and talent to make a real impact in the fast-growing neurovascular stroke market, we would love to talk with you!

Regulatory Affairs Specialist II

Location: Eden Prairie, MN

Job Description

Support regulatory activities related to projects in development and for projects where maintenance activities are necessary in Neurosciences. Responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance. This includes US and European regulatory submissions and compliance. Maintain regulatory approvals. Support the development of domestic and international regulatory approval strategies. Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings. Coordinate, compile, and submit U.S. and EU regulatory filings for new and modified products, including pre-submissions, IDEs, 510(k)s CE Mark submissions under MDR. Responsible for compiling and submitting product complaints per local reporting requirements. Perform technical and labeling reviews of supporting documents for inclusion in regulatory filings. Represent Regulatory Affairs on cross functional projects which may include product development and manufacturing process changes to provide regulatory guidance. Support audit activities, ensuring sufficient preparation. Remain up-to-date on changing Medical Device Regulations (including EU MDR) in US and EU, and other geographies per company needs. Demonstrate understanding of regulatory body review timelines and anticipate how that impacts overall product approvals. Update department procedures and documentation as needed and submit change orders. Position allows working from home within commuting distance of worksite location.

Job Requirements

The qualified candidate must have at least a Bachelor’s degree or foreign equivalent degree in life sciences, regulatory affairs, regulatory affairs and services, pharmacy, engineering, or closely related field. The qualified candidate must have at least 1 year and 6 months (18 months) of experience with all the following: (a) working in regulatory affairs with the medical device industry; (b) working directly with FDA, notified bodies and/or international health authorities; (c) knowledge of relevant US, EU, and international regulatory requirements for medical devices including Quality Systems standards; (d) utilizing all the following tools/technologies: Microsoft Word, Excel, PowerPoint and Adobe Acrobat. All experience may be gained concurrently.

MIVI is always looking for talented and creative people.

Please feel free to send an email to: careers@mivineuro.com

MIVI Neuroscience is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

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