About this opportunity
UNAVAILABLE lists this Global Regulatory Affairs Leader — Medical Devices opportunity in norcross, Georgia. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Werfen is seeking a Senior Principal Regulatory Affairs Specialist to lead regulatory and quality system support for U.S., Canada, and EU product lines. You will coordinate submissions (510(k), BLA, and device licenses) and maintain technical documentation, ensuring compliance with SOPs and global standards.
The role requires at least eight years of regulatory affairs experience in medical devices and strong knowledge of design controls, FDA regulations, and EU MDR/IVDR.
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Worksite address
norcross, GA, 30092, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.