Regulatory Associate

2 days ago

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4DMedical

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4D Lung Imaging • Regional Quantitative Analysis

51 - 200

💰 Post-IPO Equity on 2023-05

Description

• Responsible for executing product submissions and maintenance of product regulatory status • Critical role in product release activities, ensure regulatory product compliance • Implement regulatory strategies to support product development, registration, and commercialization • Coordinate interactions with regulatory agencies, including preparation and submission of documentation • Collaborate with cross-functional teams to ensure regulatory requirements are effectively implemented • Support the Director of Regulatory Affairs to resolve issues during product review and approval • Ensure accurate product labelling, marketing materials, and product claims • Execute preparation and maintenance of regulatory submissions and documentation • Assist other employees on specified projects or tasks as needed

Requirements

• 4 year degree, preferably in a science-related discipline • Clinician with experience in clinical application of Software use in the medical imaging field • Master’s degree in Business / Science or equivalent is a plus • 3+ years working with Software as a Medical Devices in Regulatory affairs is essential • FDA eSTAR and Health Canada submission experience • Experience communicating with cross-functional teams to support product development • Demonstrated writing skills in the medical devices industry • Intermediate proficiency in Microsoft Office suite Desirable • Basic understanding of human anatomy and physiology • Regulatory Affairs Professionals Society (RAPS) medical device certificate OR certification

Benefits

• 4 weeks holiday • other great USA based benefits