2000 16th Street,Denver,Colorado,80202,United States of America

At DaVita, we find that our best leaders are those who create an inspiring vision for the future and empowers their team to achieve success. They have always enjoyed tackling difficult problems and believe that the best way to solve them is through collaborative, team efforts. They take ownership of results and instill accountability in those they lead. They are driven, strong communicators, relationship builders, and find real fulfillment in challenging work.

Sound like you? Then you might be a great fit for Director, Compliance - Clinical and Quality Management Systems with DaVita.

Here is what you can expect when you join our Village: A "community first, company second" culture based on Core Values that really matter. Clinical outcomes consistently ranked above the national average. Award-winning education and training across multiple career paths to help you reach your potential. Performance-based rewards based on stellar individual and team contributions. A comprehensive benefits package designed to enhance your health, your financial well-being, and your future. Dedication, above all, to caring for patients suffering from chronic kidney failure across the nation.

General Purpose of Position: This position will report directly to the Deputy Chief Compliance Officer ("CCO"). The Director will be primarily responsible for designing, establishing, and maintaining a new Quality Management System ("QMS") for a software medical device ("SaMD") in compliance with all Food & Drug Administration ("FDA") laws and regulations including, but not limited to the Federal Food, Drug, & Cosmetic Act, 21 CFR Part 820 for medical devices, and ISO 13485:2016 for medical devices. The Director may also support other compliance projects, as determined

Job Responsibilities: Serving as project leader for the design, establishment, and long-term maintenance of the new QMS for this SaMD. Leading annual risk assessment process to inform annual QMS plan and objectives. Developing and executing on QMS annual plan and objectives with internal clinical, IT, legal, and other stakeholders. Serving as the Company's owner of this QMS and leading the applicable QMS review boards and governance committees. Developing and presenting QMS updates to DaVita's Management Compliance Committee and the Board of Directors Compliance and Quality Committee. Developing, reviewing, and implementing required QMS policies and procedures including the QMS quality manual. Participating in process to review any changes to SaMD ensuring any changes are made in compliance with policies, procedures, and applicable laws and regulations. Partnering with compliance communications and training team to promote awareness of QMS requirements and to create and deliver all required QMS trainings and required tracking. Developing and executing monitoring and auditing activities in partnership with internal and external auditors to ensure compliance with all policies and procedures and applicable laws and regulations including, but not limited to 21 CFR Part 820 for medical devices, and ISO 13485:2016 for medical devices 2016. Partnering with compliance investigations team to conduct any required investigations resulting from QMS activities. Developing and monitoring of all corrective action activities resulting from QMS activities including monitoring, auditing, and investigations. Overseeing and responding to all regulatory requests, audits, or inspections by FDA or other government agencies. Overseeing supplier management activities including maintenance of the approved supplier list and reviewing supplier evaluations, if applicable. Overseeing the QMS complaint handling processes, reporting, monitoring, and corrective actions. Partnering with legal and other departments to lead the compiling and reviewing of regulatory filings, including 510(k) sub issions, as needed. Job location: Denver or remote. Limited travel required.

Qualifications and Experiences Bachelor's degree required; advanced degree in Law, Business Administration, Engineering, Science, or Information Management preferred. Minimum of 5 years of experience in the legal, compliance, regulatory, quality, consulting, and/or a similar role in the medical device industry. Experience required with designing, establishing, and maintaining a Quality Management System for a SaMD or a medical device. Experience required in working with applicable laws, regulations, and medical device international standards, including: 21 C.F.R. Part 820 ISO 13485:2016. ISO 9001:2015. ISO 14971:2019. Experienced leader who has: Strong organizational and project management skills with demonstrated attention to detail. Experience successfully managing relationships with a high energy and diverse group of leaders across organizational departments. Ability to effectively communicate and distill important aspects of any issue to a wide audience of participants. Proven ability to "Get Stuff Done" with a bias for action and a keen sense of accountability. Solid technology skills including Excel and PowerPoint.

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