Senior Regulatory Affairs Principal

Job not on LinkedIn

October 27

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

⏰ Full Time

🟠 Senior

🚔 Compliance

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DeepHealth

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Artificial Intelligence • Healthcare Insurance • SaaS

DeepHealth is a global leader in AI-powered health informatics, providing innovative solutions designed to enhance operational efficiency and clinical confidence in radiology. As a wholly-owned subsidiary of RadNet, Inc. , DeepHealth offers a comprehensive suite of diagnostic and imaging tools, including the DeepHealth OS, a pioneering cloud-native operating system. Their AI-powered solutions support large-scale diagnostic programs and streamline workflows in areas such as breast, prostate, lung, and brain cancer detection. DeepHealth collaborates with leading healthcare institutions worldwide to transform radiology practices and improve care delivery.

11 - 50 employees

🤖 Artificial Intelligence

⚕️ Healthcare Insurance

☁️ SaaS

💰 $225k Grant on 2019-08

📋 Description

• Develop and execute the regulatory strategy for DeepHealth’s high risk (FDA Class III) devices. • Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for high risk medical devices. • Lead and manage regulatory submissions, including FDA Q-submission, US 510(k)s submissions, Premarket Approvals (PMA) submissions, supplements, and reports, including Regulatory Body interactions. • Work closely with business partners and regulatory team members to ensure compliance for and support of regulatory submissions and filings. • Monitor and interpret evolving global regulations, standards, and guidance documents to ensure the company’s regulatory compliance, translating them into action steps for the organization. • Create and ensure maintenance of technical documentation as required for obtaining and/or maintaining regulatory approval/clearance for DeepHealth products.

🎯 Requirements

• Bachelor’s degree in a life science, engineering, or related scientific field is required. • An advanced degree or Regulatory Affairs Certification is preferred. • 13 - 17 years working in a regulated industry (FDA and Software as a Medical Device preferred). • Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820. • Knowledge and experience drafting and submitting regulatory filings, including but not limited to, Q-Submission requests, Traditional 510(k) filings, and Premarket Approval for Software as Medical Device. • Experience with US FDA Class III devices required; OUS device classification preferred. • Experience interacting with US and OUS Regulatory Authorities, including Q-Submission meetings, product Deficiency Response meetings, and regulatory inspections. • Experience with FDA’s Total Product Life Cycle Advisory Program (TAP) and Breakthrough Designation a plus. • International submission experience in Australia, Canada, Brazil, and Japan for high risk devices. • 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.

🏖️ Benefits

• Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.