We have an opportunity with a stable, mid-sized company in the Minneapolis-St Paul metro area. The company has been growing steadily the last several years and has plans to continue that growth. This is a fast moving company with seasoned leadership looking for individuals who have a solid 4-6+ years’ experience in Class II or III medical devices.
The role will prepare and submit submissions for US (510(k), PMA supplements and internationally. This person will serve as regulatory representative on selected projects for new product development or line extensions and will provide regulatory supervision on post-market product changes to maintain marketing approvals.
This position will afford a hungry, humble and smart candidate the opportunity to build their experience and become well versed in not only US submissions but the International space as well. In this role, 50% of your time to be focused on US devices (510(k) and PMA Supplements. The other time would be divided on working on EU, Canada, Australia, Brazilian, Japanese, and other international submissions to support business growth as well as including sustaining activity in both the US and EU.
Candidates must have written, at minimum, one entire 510(k) for a Class II or III medical device by themselves to be considered. Additional submissions such as PMA supplements and EUMDR Class III experience will also be considered.