
Global SaMD Regulatory Lead - Submissions & Strategy
Wolters Kluwer, New York, NY, United States
A leading technology and information services company is seeking a Senior Regulatory Affairs Specialist to support the growth of their Software as a Medical Device (SaMD) portfolio. The role requires expertise in global regulations, including FDA and EU MDR submissions, and involves advising product teams on regulatory pathways. Candidates should have a bachelor's degree in Life Sciences or Engineering and 5-7 years of regulatory experience. This position includes a competitive salary range of $85,600 - $149,400 and offers various benefits including medical, dental, and tuition assistance.
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