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UnitedHealth Group

UnitedHealth Group is looking for a Medical Device Regulatory Affairs Director  #SeekingEmploymentInPagosaSprings #OnlineJobsNearPagosaSprings #DirectorJobsPagosaSprings #MedicalJobsPagosaSprings

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 doing your life’s best work.(sm)The Optum Medical Device Program (OMDP) Regulatory Affairs Director is the leader of the newly created OMDP team. Optum is seeking a highly skilled, experienced and motivated  individual for this critical new role to develop the overall OMDP strategy providing regulatory affairs leadership and support in connection with  the development and evaluation of newly created products and the review and maintenance of existing products and software against medical device and SaMD regulations. This role will represent OMDP in broader Optum product strategic activities including negotiations with FDA and other relevant regulatory agencies.With rapid growth in development of new products with heightened functions and capabilities, this role is critical in leading the OMDP team as it develops and manages the overall medical device strategy for Optum.  This strategy will include providing regulatory affairs expertise and guidance to business partners from evaluation of potential products to supporting the entire product lifecycle of a medical device product. This individual will be managing the ODMP team day-to-day functions, but also drive Executive Level reporting and communications. In this highly visible role, the successful candidate will be able to routinely flex between technical details and big-picture strategic planning. Youll enjoy the flexibility to telecommute* from anywhere within the U.S. as you take on some tough challenges.Primary Responsibilities: Lead the Optum Medical Device Program (ODMP) team including development, documentation and implementation of overall OMDP regulatory strategy to plan and support product development and company goals, operational policies and processes, and reporting to Executive level business leaders Develop and manage OMDP oversight processes for established medical device products Develop and manage OMDP product review processes (e.g. device determinations) Serve as communicator with all regulatory agencies for both oral and written communications and reporting, ensuring reports are compiled, approved, and distributed to appropriate internal personnel as well as external agencies. Also manages the preparation and quality check of all regulatory submissions to regulatory agencies. Partner closely with business leaders to advise on the FDA submission strategy Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies Compile materials for license renewals, updates and registrations Maintain regulatory files/database to support compliance with regulatory requirements. Establish and maintain system for tracking changes in documents submitted to agencies or partners Review and advise on labeling and labels for compliance with regulatory requirements Review changes to existing products and SOPs to define the requirements for regulatory submissions Provide the regulatory reviews of customer complaints and define the regulatory reportabilityYoull 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.Required Qualifications: Bachelors degree 10+ years in medical device regulatory affairs 2+ years of leadership experience Experience with FDA submissions and engagement Experience supporting FDA audits and communications Experience in executive level communications and presentations Travel up to 20% If you need to enter a work site for any reason, you will be required to screen for symptoms using the ProtectWell mobile app, Interactive Voice Response (i.e., entering your symptoms via phone system) or a similar UnitedHealth Group-approved symptom screener. 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 attainedPreferred Qualifications: Experience with Software as a Medical Device (SaMD) products Experience with EU, globalCareers with Optum. Here’s the idea. We built an entire organization around one giant objective; make health care work better for everyone. So when it comes to how we use the world’s large accumulation of health-related information, or guide health and lifestyle choices or manage pharmacy benefits for millions, our first goal is to leap beyond the status quo and uncover new ways to serve. Optum, part of the UnitedHealth Group family of businesses, brings together some of the greatest minds and most advanced ideas on where health care has to go in order to reach its fullest potential. For you, that means working on high performance teams against sophisticated challenges that matter. Optum, incredible ideas in one incredible company and a singular opportunity to do your life’s best work.(sm)Colorado Residents Only: The salary range for Colorado residents is $130,300 to $250,200. Pay is based on several factors including but not limited to education, work experience, certifications, etc. As of the date of this posting, In addition to your salary,  UHG offers the following benefits for this position, subject to applicable eligibility requirements: Health, dental, and vision plans; wellness program; flexible spending accounts; paid parking or public transportation costs; 401(k) retirement plan; employee stock purchase plan; life insurance, short-term disability insurance, and long-term disability insurance; business travel accident insurance; Employee Assistance Program; PTO; and employee-paid critical illness and accident insurance.*All Telecommuters will be required to adhere to UnitedHealth Groups Telecommuter Policy. 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.UnitedHealth Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.Job Keywords:  Medical Device Program Regulatory Affairs Director, Telecommute, Telecommuter, Telecommuting, Work at Home, Work from Home, Remote Recommended SkillsNew Product DevelopmentLeadershipReportsProduct LifecycleStrategic ThinkingCommunicationRecommended JobsDirectorDirector Of Regulatory AffairsAtlanta,GaDirector Of Regulatory Affairs, Atlanta,GaMedical Device Regulatory Affairs DirectorUnitedHealth GroupWork From HomeFull Time
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