Vice President - Regulatory Affairs

December 5, 2024

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Precision Neuroscience

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Precision Neuroscience is a cutting-edge company focused on developing brain–computer interface technology intended to seamlessly connect human and artificial intelligence. Their flagship product, the Layer 7 Cortical Interface, is a minimally invasive brain implant that can be placed anywhere on the brain surface, capable of recording and translating brain signals to operate digital devices. Precision Neuroscience aims to revolutionize medical treatment and enhance human capabilities by creating life-changing neural interface systems.

brain-computer interfaces • medical device • neuroscience • neurology • BCI

11 - 50 employees

🧬 Biotechnology

🤖 Artificial Intelligence

⚕️ Healthcare Insurance

💰 $41M Series B on 2023-01

📋 Description

• Precision is building a direct connection between the human brain and computers to benefit those with neurological conditions. • Seeking a Vice President of Regulatory Affairs to lead regulatory strategies for medical devices. • Work closely with product and clinical teams to ensure FDA and global compliance. • Position based in Manhattan, Santa Clara, or remote, with a focus on innovation and collaboration.

🎯 Requirements

• Proven track record of successful FDA regulatory submissions and clearances, particularly with Class III medical devices and complex systems integrating hardware and software. • Extensive experience interfacing directly with the FDA and other regulatory agencies. • Demonstrated expertise in drafting and executing regulatory submissions for FDA approval including 510(k), Breakthrough, DeNovo, and PMA applications • Experience in dynamic company environments including small to medium-sized organizations. • Extensive experience with IDE submissions, post-market surveillance, and regulatory audits. • 10 years of regulatory experience in the medical device industry, with at least 5 years in a senior or executive regulatory role. • Bachelor’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs or a related field is required. • Advanced Degree (e.g., MS, MBA, or PhD) in Life Sciences, Regulatory affairs or a closely related field is strongly preferred. • RAPS and ISO 13485 certification or equivalent experience • Strong-decision making and project management abilities, with the capability to manage multiple initiatives simultaneously. • Exceptional verbal and written communication skills, with the ability to communicate complex regulatory concepts clearly to FDA, internal teams, and leadership. • High attention to detail, analytical skills, and a proactive, solution- oriented approach to regulatory challenges. • Excellent communication and collaboration skills, with experience working in cross-functional teams. • Ability to thrive in a fast-paced, innovative environment.