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.
#J-18808-LjbffrGlobal Regulatory Affairs Principal Leader – Medical Devices in norcross at Unknown Company
This position is listed as full time and onsite.