Senior Regulatory Affairs Lead, Medical Devices Submissions
Listed on 2026-10-06
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Healthcare
Healthcare Compliance, Medical Science Liaison, Medical Device Industry, Medical Science
Fresenius Medical Care seeks an experienced Regulatory Affairs professional to develop and manage regulatory strategies for medical devices in the US and international markets. You will lead cross-functional teams to ensure compliance and timely FDA submissions while guiding regulatory risk assessments.
The role requires a Bachelor's degree and 8+ years of related submission experience, including 510(k) know-how; advanced degree and global regulation exposure are a plus.
We are seeking a motivated Senior Regulatory Affairs Lead, Medical Devices Submissions to join Freseniusmedicalcare in Waltham, MA, United States.
This posting is for the Senior Regulatory Affairs Lead, Medical Devices Submissions role at Freseniusmedicalcare, based in Waltham, MA, United States.
We are looking to fill the Senior Regulatory Affairs Lead, Medical Devices Submissions position at Freseniusmedicalcare in Waltham, MA, United States.
The Senior Regulatory Affairs Lead, Medical Devices Submissions role at Freseniusmedicalcare is now open for applications in Waltham, MA, United States.
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