Senior Regulatory Affairs Lead - SaMD/MedTech (Remote
Remote / Online - Candidates ideally in
Madison, Morris County, New Jersey, 07940, USA
Listed on 2026-08-23
Madison, Morris County, New Jersey, 07940, USA
Listing for:
OrganOx Limited
Full Time, Remote/Work from Home
position Listed on 2026-08-23
Job specializations:
-
Healthcare
-
Quality Assurance - QA/QC
Job Description & How to Apply Below
Organ Ox Limited is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions for North America, including FDA activities for SaMD/SiMD and electromechanical devices. The role requires collaborating with Manufacturing, Quality, R&D, and Marketing to ensure compliance with ISO, GMP, and medical device standards.
The position offers flexible remote or hybrid on-site work in Madison, NJ with travel up to 5% domestically or internationally, and reports to the Director of
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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