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OrganOx Limited

Hybrid Senior Regulatory Affairs Lead, Medical Devices

madison, NJ

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About this opportunity

OrganOx Limited lists this Hybrid Senior Regulatory Affairs Lead, Medical Devices opportunity in madison, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.

Job description

OrganOx Limited in Madison, NJ, offers a hybrid Senior Regulatory Affairs Specialist role focused on leading regulatory activities for medical devices across lifecycle, including US and international submissions. You will work closely with Manufacturing, Quality, R&D, and Operations to ensure compliant product changes and registrations.

The ideal candidate has 5+ years in regulatory affairs for medical devices, strong technical writing skills, and experience with US Class III submissions.

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Worksite address

madison, NJ, 07940, US

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