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Regulatory Manager

Company: 11 Health & Technologies
Location: Irvine
Posted on: December 3, 2019

Job Description:

11 Health and Technologies is looking for an experienced regulatory professional to join our team as we expand into new technologies and markets. 11 Health is a fast-paced, medical technology company, helping people living with medical bags by combining peer-to-peer lifestyle education and support with SmartBags that collect patient generated data for preventative care. Combining smart technology with the world's first one to one Patient Coach Program that provides both technical and emotional support to patients, we have a complete care management platform that is the new gold standard in healthcare for both patients and clinicians.Essential Duties and ResponsibilitiesThis position serves as a subject matter expert on the regulatory issues that impact an international medical technology company using internal resources, regulatory agencies, and outside consultants as needed. The position reports to the Chief Commercial Officer.Responsible for providing guidance to assure that all regulatory submissions are planned, communicated and executed to meet regulatory and business requirements.Identify and draft domestic and international strategies and regulatory submission plans and options to obtain product and service approvals.Perform regulatory assessment (FDA, CE marking) of new products and services.Provide regulatory affairs assessment for change control documents to ensure compliance to regulations and notification of significant changes to the respective regulatory authority body. Serve as primary contact for regulators' and external governmental auditors' concerns, inquiries, audits, and investigationsCoordinate investigations and corrective action plans regarding regulators' and external auditors' concerns and interact with regulatory agencies with facilities inspections, licensures and permits.Provide regulatory opinion for complex or unique issues and challenges regarding registration and compliance activities.Maintain current knowledge of California Department of Public Health and Joint Commission standards for the company's products and services and other relevant standards and requirementsIdentify and clearly link deficient practices with related CMS regulations and TJC standards with potential system vulnerabilities and related organization risk pointsKeep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.Conduct training and/or communicate appropriate materials and provide active and ongoing regulatory guidance to project teams in order to enhance team's knowledge of working in a regulated environment.Enhance and create internal policies and procedures.Participate in business meetings with potential new external partnersSupport regulatory compliance to QSR, ISO, CMDR and other worldwide regulatory requirements as appropriate through customer complaints, internal audits and training systems.Research competitor products and create summaries for departmental use.Candidates will possess the following skills:Project management skills including coordination, communication, prioritization, troubleshooting, and completion goals.Excellent communication, persuasive and interpersonal skills with the ability to communicate across all levels of the organization, including technology, tools, and processes.Problem solving skills enabling the identification and resolution of problems in a timely manner.Organizational skills enabling the prioritization and planning of work activities, efficient use of time, and development of ambitious but realistic action plans.Ability to adapt quickly to changes in scope or direction and flexibility to adopt changes quickly.High level of motivation and the ability to work in a fast-paced environment with little supervision.Ability to exercise a high level of judgment, initiative and discretion in confidential and sensitive matters.Education and/or Experience/ Minimum Requirements:3 years minimum regulatory experience in healthcareBS in life science minimumExpert knowledge in Microsoft Office (Word, Excel, PowerPoint, SharePoint, Outlook).Job Type: Full-timeLocation: Irvine, CA (Required)Work authorization: United States (Required)Benefits/ CompensationA competitive compensation and benefits package will be made available to the qualified candidate, -

Keywords: 11 Health & Technologies, Irvine , Regulatory Manager, Executive , Irvine, California

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