Vice President - Regulatory Affairs

December 5

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Precision Neuroscience

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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.