Senior Regulatory Specialist

Summary

Join a dynamic team with expertise in various fields at RadNet's AI division, where you'll collaborate on advancing healthcare through artificial intelligence.

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
• 6-8 years working in a regulated industry (FDA and Software as a Medical Device preferred)
• Knowledge and experience drafting and submitting regulatory filings, including but not limited to, Q-Submission requests, and Traditional and Special 510(k) filings. Filings for Software as Medical Device preferred
• Experience with US FDA Class I and II medical devices. Additional experience with FDA Class III devices and OUS device classification a plus
• Experience interacting with Regulatory Authorities, including Q-Submission meetings, and product Deficiency Response meetings, and regulatory inspections
• Knowledge and understanding of pre- and post- market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56
• Knowledge and understanding of Medical Devices Regulations (MDR 2017/745. MDCG 2019-11, MDCG 2020-1), ISO 13485, and MDSAP, ISO 14971, ISO 62366, IEC 82304-1, IEC 62304, preferred
• Excellent written and oral communication skills

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

• Fully remote working environment with Flexibility in work hours
• A salary in line with job level and experience