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Regulatory Operations Specialist

Company: Eko Devices
Location: Oakland
Posted on: June 6, 2021

Job Description:

Join Eko in our mission to improve the way clinicians detect and monitor cardiac and respiratory disease. Eko is a platform of advanced FDA-cleared sensors, patient and provider software, and AI-powered analysis used by clinicians at over 4,000 U.S. hospitals. Duties and Responsibilities Act as Regulatory document coordinator for numerous clients (internal and external stakeholders) in order to process all regulatory submission documents through internal and external systems in a timely manner. Create regulatory portals and maintain them within US and other global regions and maintain yearly actions and fees Maintain a computer database of all filed documentation that ensures fast retrieval of documents Maintain electronic and hard-copied controlled regulatory documents, regulatory department files and resource materials Work with Sr. Dir of regulatory affairs to ensure timely distribution of latest revision level regulatory documentation to all appropriate users internal and external Maintain logs of all communications with regulatory bodies Work with regulatory team to fill/review change orders for products in US and OUS Work with team to maintain external documents /standards Edit and assist in drafting submissions in US and globally Support regulatory training of other team membersSupport company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations Qualifications 1-3 years of experience in the medical device industry. Ability to perform word processing and create basic spreadsheets, as well as work in Adobe and numerous on-line media A high attention to detail and orderly focus Project management and time management skills Will be a pro-active problem solver Work to maintain efficiency and quality balance in your work Team player Ability to prioritize across numerous projects and varying dates Eko is elevating the way clinicians detect and monitor cardiac and respiratory disease by bringing together advanced sensors, patient and provider software, and AI-powered analysis. Its FDA cleared platform is used by tens of thousands of clinicians treating millions of patients around the world, in-person, and through telehealth. The company is headquartered in Oakland, California and privately-held, with investments from ARTIS Ventures, NTT Venture Capital, DigiTx Ventures, Mayo Clinic, Sutter Health and others. Eko is proud to be an equal opportunity employer and welcome people of different backgrounds, experiences, abilities and perspectives. We celebrate diversity and are committed to building a diverse and inclusive team.

Keywords: Eko Devices, Oakland , Regulatory Operations Specialist, Other , Oakland, California

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