DeepHealth is hiring a
Regulatory Specialist in United States

Summary

The job description is for a Regulatory Specialist (US) position at RadNet's AI division, DeepHealth. The role involves ensuring regulatory compliance for product markets, creating technical documentation, and working with clinical teams to ensure compliance for pre- and post-market clinical studies. The position requires a Bachelor’s degree in a relevant field, strong knowledge of FDA Quality System Regulations, and 2-4 years of experience in a regulated industry.

Requirements

• Bachelor’s degree in relevant field (or equivalent experience)
• Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820
• 2 - 4 years working in a regulated industry (FDA and Software as a Medical Device preferred)

Responsibilities

• Plan, define and coordinate relevant process related to product Regulatory approval, including but not limited to, FDA clearance, and/or CE Marking
• Actively liaise and closely collaborate with engineering and product teams to ensure regulatory compliance for product markets
• Provide regulatory guidance to the development teams for registration of products
• Create and ensure maintenance of technical documentation (such as clinical evaluation reports, risk management reports, 510(k) notification) as required for obtaining and/or maintaining regulatory approval/clearance for DeepHealth products
• Plan, execute and document (clinical) risk assessment sessions with relevant internal and external experts
• Work with the clinical teams to ensure compliance for pre- and post-market clinical studies in support of DeepHealth products and product changes
• Enforce compliance to applicable standards and escalate to appropriate authorities if needed
• Ensuring timely submission of adverse events to the appropriate regulatory bodies

Benefits

• Join a dynamic team with expertise in various fields
• Collaborative and agile work environment
• Continuous learning opportunities to enhance your professional skills
• Fully remote working environment with Flexibility in work hours