Regulatory Specialist - US

Company

RadNet is a public company operating 350+ medical imaging centers across the US. Its AI division - comprising subsidiaries Aidence, DeepHealth, and Quantib - develops and markets AI-based software products for the early detection of breast, lung, and prostate cancers with the purpose of bringing the world's best doctor to every patient.

In the AI division, we are dedicated to addressing the most complex challenges faced by radiologists and enhancing their ability to focus on valuable tasks. Medical images hold the secrets to diseases that both physicians and we aim to unveil. Our mission is to empower radiologists with fast and accurate artificial intelligence software, enabling them to detect even the subtlest changes within the human body. If you're passionate about advancing healthcare through artificial intelligence, we invite you to join our team.

We are not just a workplace; it's a collaborative environment where teamwork is paramount. We're a close-knit, growing team, embracing an agile approach that allows us to swiftly adapt to challenges and opportunities alike.

Role Summary
The Regulatory Specialist (US) is responsible for supporting DeepHealth’s product and product development, ensuring compliance with the relevant regulatory requirements and interactions with regulatory authorities.

Essential Duties and Responsibilities

As the Regulatory Specialist, this position will:

• 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.

Minimum Qualifications, Education and Experience
Qualifications include:

• 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. 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