Senior Regulatory Affairs Lead - SaMD/MedTech; Remote
Madison, Morris County, New Jersey, 07940, USA
Listed on 2026-10-07
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Healthcare
Medical Science Liaison, Healthcare Compliance
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
This role, Senior Regulatory Affairs Lead
- SaMD/Med Tech (Remote) at Organ Ox Limited, could be your next move.
The advertised compensation is 110..
We aim to respond to suitable candidates as soon as possible.
Full responsibilities and requirements are described in the listing above.
Learn more about the Senior Regulatory Affairs Lead
- SaMD/Med Tech (Remote) role in the description above.
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