Regulatory Affairs Specialist

Summary

Join DeepHealth as a Regulatory Specialist (US) and support product development while ensuring compliance with regulatory requirements. You will plan and coordinate regulatory approval processes, collaborate with engineering and product teams, provide regulatory guidance, and maintain technical documentation. Responsibilities include risk assessment, working with clinical teams, enforcing compliance, and submitting adverse events. This role requires a Bachelor's degree, strong knowledge of FDA regulations, and relevant experience in a regulated industry. The position offers remote work flexibility.

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)
• Knowledge and experience drafting and submitting regulatory filings, including but not limited to, Q-Submission requests, and Traditional and Special 510(k) filings
• Experience with US FDA Class I and II medical devices
• 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
• 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

Preferred Qualifications

• Filings for Software as a Medical Device
• Additional experience with FDA Class III devices and OUS device classification
• 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

Benefits

This position will have the ability to work remotely