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Regulatory Specialist

Company: Jobleads
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 Assist/lead US regulatory submissions and creation of submission and regulatory documentation. Assist/lead EU MDR regulatory submissions and creation of submission and regulatory documentation. Help the organization with implementation and maintenance of EU MDR and maintain CE marking. Assist with EU MDR and CE marking and surveillance audits. Assist in gathering requirements and documentation and help build regulatory guidance and strategy. Assist with regulatory project plans and timelines and ensure all projects are appropriately prioritized and key goals are met on time. Work with internal and external partners on planning and execution of projects and help with timely communication with external partners and present the company in meetings. Assist/Oversee compilation, electronic processing, and publishing to ensure high quality and timely electronic submissions compliant with regulatory authority requirements. Oversee the maintenance and creation of relevant SOPs, Work Instructions, and other necessary guidance. Lead maintenance of the change management process internally and change management notifications and amendment submissions with US FDA, EU MDR and Health Canada. Qualifications Bachelor or higher degree degree in a scientific field required. 5 years of experience in Regulatory/global Regulatory Affairs for medical devices, software as a medical device and digital health. Must have strong Regulatory experience with US FDA and also outside the US and EU MDR, MDD. Positive attitude and willing to roll up your sleeves to get the job done; ability to pay close attention to detail and step back and think strategically. Strong interpersonal verbal, written and presentation skills in communication with internal and external parties. Must be comfortable working for a small organization, and able to handle ambiguity. 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: Jobleads, Oakland , Regulatory Specialist, Other , Oakland, California

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