Regulatory Specialist

March 29

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DeepHealth

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Meticulous science. Mindfully delivered.

11 - 50

💰 $225k Grant on 2019-08

Description

• 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.

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. 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.

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. • A salary in line with job level and experience.