FDA 510(k) Compliance Expert for Monitoring Device

I'm seeking a professional with extensive knowledge and experience in navigating the FDA 510(k) compliance process for a monitoring medical device. This device will be tracking patient vital signs. Key Responsibilities: - Developing a robust regulatory strategy for the device - Assisting with the submission process to the FDA Ideal Skills and Experience: - Proven track record of FDA 510(k) submissions - Deep understanding of regulatory strategies for medical devices - Experience with monitoring equipment and patient vital signs devices - Excellent communication skills for effective liaising with regulatory bodies