About this opportunity
Werfen lists this Global Regulatory Affairs Principal 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 support regulatory affairs and quality systems for US, Canada, and EU markets. You will drive submissions (510(k), BLA), maintain technical files, and ensure compliance across global regulatory requirements.
The ideal candidate has 8+ years in medical device regulatory affairs, with strong knowledge of FDA and EU regulations, ISO 13485, and risk management frameworks.
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Worksite address
norcross, GA, 30092, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.