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Jacobs Management Group

Senior Regulatory Affairs Associate Regulatory Specialist Medical Devices

Jacobs Management Group, Carlsbad, California, United States, 92002

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Step into a role where your regulatory expertise helps bring life-enhancing medical technologies to market. My client is seeking a driven Senior Regulatory Affairs Associate to support U.S. and global submissions for innovative devices developed in Carlsbad, CA. Your work will directly impact patient access to groundbreaking neuromodulation therapies. Why You Should Apply Help bring cutting-edge neuromodulation devices to market High-impact role supporting global regulatory submissions Be the regulatory expert on a collaborative, cross-functional team What Youll Be Doing Developing and executing regulatory strategies for U.S. and international submissions Preparing and submitting FDA 510(k)s, PMAs, technical files, and change orders Serving as a subject matter expert on regulatory guidelines and inspections Supporting cross-functional teams on product development and changes Advising on regulatory impacts of decisions and submissions globally About You Be able to do the job as described 8+ years of experience in medical device regulatory affairs Knowledge of neuromodulation products or similarly complex devices is a plus Familiarity with global regulatory frameworks beyond the FDA Degree in engineering, science, or a related technical field How To Apply Wed love to see your resume, but we dont need it to have a conversation. Send an email to ccupo@jacobsmgt.com and tell me why youre interested. Or, if you do have a resume ready, apply here. #J-18808-Ljbffr