1+ months

Director of Quality and Regulatory Affairs - Plano, TX - 914834

Plano, TX 75074
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  • Job Code
    914834

Combine two of the fastest-growing fields on the planet with a culture of performance, collaboration and opportunity and this is what you get. Leading edge technology in an industry that's improving the lives of millions. Here, innovation isn't about another gadget, it's about making health care data available wherever and whenever people need it, safely and reliably. There's no room for error. Join us and start doingyour life's best work.(sm)

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The Regulatory Affairs and Quality Assurance Director is responsible for maintaining and ensuring Vivifiys regulatory affairs and quality assurance programs comply with the appropriate FDA regulatory standards.

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Primary Responsibilities:

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  • Provide Quality and Regulatory leadership and direction to Vivify executive team
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  • Work collaboratively with various functional areas to establish and maintain a comprehensive Quality Management System that meets all applicable FDA Medical Device regulations and ISO standards
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  • Monitor performance and effectiveness of the Quality Management System and keep leadership informed on progress, trends, issues, risks, and necessary remediation plans
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  • Lead quality-related internal audit activities, corrective and preventative actions, continuous improvement and other quality initiatives consistent with defined quality plans
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  • Participate in developing global regulatory strategies for Class 1 and Class 2 medical devices
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  • Support interactions with regulatory agencies during inspections, adverse event reporting, and other regulatory activities
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  • Participate in cross-functional teams with respect to new product development, labeling and marketing material review, vendor management, process improvement, and general operations
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  • Develop and mentor personnel to build overall team expertise
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  • Ensure promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization
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Youll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.

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Required Qualifications:

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  • Bachelors degree or superior education
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  • 10+ years of increasingly experience in Regulatory Affairs and Quality Assurance in the medical device industry
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  • 5+ years of management work experience in Regulatory Affairs and Quality Assurance.
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  • Advanced knowledge of 21 CFR 820 and ISO 13485:2016
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  • Direct, hands-on experience in implementing and maintaining an effective Quality Management System
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  • Experience preparing for and passing and FDA Audit
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  • Experience in preparing and filing regulatory submissions
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  • Employees are required to screen for symptoms using the ProtectWell mobile app, Interactive VoiceResponse (i.e., entering your symptoms via phone system) or a similar UnitedHealth Group approved symptom screener prior to entering the work site each day, in order to keep our work sites safe. Employees must comply with any state and local masking orders. In addition, when in a UnitedHealth Group building, employees are expected to wear a mask in areas where physical distancing cannot be attained
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Preferred Qualifications:

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  • Bachelors degree in Engineering, Biological Science or related technical discipline
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  • ASQ certification Manager of Quality (CMQ) and Quality Auditor (CQA)
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  • Knowledge and experience with convenience kitting
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  • Knowledge and experience with software as a medical device
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Opportunities with Vivify Health. Vivify Health specializes in patient engagement and mobility to provide a scalable Remote Care Platform that enable healthcare to be virtualized . . . anytime and anywhere. More often than not, that anywhere is the home, which is where Vivifys customers have been virtualizing care with mobile devices since early 2010. Vivify Healths customers represent organizations with responsibilities for hundreds of acute care and home care sites nationwide. Take a closer look at Vivify Health and discover new ways to make a difference in the world as you doyour lifes best work.(sm)

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Diversity creates a healthier atmosphere: UnitedHealth Group is an Equal Employment Opportunity/Affirmative Action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law.

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UnitedHealth Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.

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Job Keywords: Medical Devices, Logistics, FDA Quality System Regulation, FDA Audit, Plano, TX, Texas, Vivify Health

Posted: 2021-02-17 Expires: 2021-05-16

UnitedHealth Group is the most diversified health care company in the United States and a leader worldwide in helping people live healthier lives and helping to make the health system work better for everyone.

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Director of Quality and Regulatory Affairs - Plano, TX - 914834

UnitedHealth Group
Plano, TX 75074

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