Job Description

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 You’ll 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

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