• Educate and develop team members • Roll out process changes and projects • Troubleshoot questions from team and outside stakeholders • Oversee RN denials management specialists • Post pre-bill utilization management reviews • Conduct calls with payer UR teams • Manage workflow and queue designation • Collaborate with Internal RCM teams

Role Description Reporting to the Senior Director of Device Quality and Regulatory (DQ&R), the Associate Director Quality Engineering & Quality Assurance is responsible for independent compliance support of Medical Devices including the device constituent part of Combination Products. This position will interact with cross functional teams working with all levels of employees. Activities will include developing, documenting, and maintenance of technical business solutions, reviewing and approving medical device/combination product documentation to support regulatory filings and audits of data, policies, procedures, and systems to ensure compliance with Medical Device (21CFR 820s) and Combination Product current Good Manufacturing ruling (21CFR part 4), Device Risk Management (ISO 14971) and other worldwide regulations and company requirements. This position provides Device quality engineering and quality assurance support and leadership to ensure successful quality oversight of prospective medical devices and medical device combination products. Primary Activities - Actively represent DQ&R Quality function on commercial and product/core development teams supporting quality issues related to medical devices or the device constituent of a combination product. - Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development, design transfer qualification and post marketing surveillance. Evaluate deficiencies and assess impact on compliance status. - Contribute to developing/revising policy and procedures for DQ&R Quality and/or supported areas. - Remain informed of industry trends as described in worldwide regulations and industry standards. - Provide guidance to our Manufacturing Division and our Research and Development Division device functions and other personnel to ensure end-to-end Design Control principles are implemented effectively. - Participate in design reviews, CAPA reviews, and ad-hoc technical reviews of combination products. - Participate in all stages of combo product development including but not limited to oversight of purchasing controls and supplier quality. - Work with external partners to develop products. - Review and approve verification/validation test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives. - Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. - Facilitate translation of customer needs into critical to quality and design input/output requirements, including but not limited to chemical, physical, or performance specifications. - Lead and manage development of Design and Development File deliverables for medical devices. Qualifications - A Bachelor’s degree in Science or Engineering or associated fields with a minimum of 7 years related experience OR a Master’s degree in Science or Engineering or associated fields and 5 years related experience OR a Ph.D. in Science or Engineering or associated fields and 3 years of related experience. - 7 years of relevant work experience. - Extensive knowledge of applicable medical device regulations (21CFR820, 21CFR Part 4, EU MDR, ISO 13485). - Experience with Design Controls / CAPA / Purchasing Controls as it related to 21CFR820. - Risk Management experience (ISO 14971/24971, ICH Q9). - Effective communication skills and working knowledge of device development and commercialization, product approval, and/or regulatory inspection experience with medical devices. - Must be able to work independently within a cross functional framework and will involve detailed technical writing and review. - A high degree of creative thinking, resourcefulness, and networking will be required to coordinate projects or solve problems. - Ability to work in a matrix organization and effective written and oral communicator. Preferred Experience and Skills - Remediation experience is desired. - Knowledge of current GMPs for combination products. - Certified Lean Six Sigma Green Belt or Black Belt or ASQ (American Society for Quality) certifications are preferred. - Strong understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (QDP); and project management principles is desirable. - Lean Six Sigma Principles and tools such as: DOEs, Root cause analysis and/or Problem-solving methods are desired. - Experience in the use of root cause analysis and applied statistical techniques. Requirements - US based – NJ/PA or other US location. - Travel – Yes, <10% of the time. Benefits - Comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family). - Retirement benefits, including 401(k). - Paid holidays, vacation, and compassionate and sick days.

Role Description An acknowledged authority on data integration, data storage, and data management, this individual will lead teams responsible for the delivery of services that help ensure success of data management throughout the enterprise. Optimizes the leverage of enterprise tool investments around data management and act as primary liaison with business units across the company requiring data integration, data storage and data management. Will draw on other teams and leverage resources from the broader Enterprise Services organization to successfully deliver on key initiatives that drive business value across the company. Will enable business development efforts by providing subject matter expertise, domain leadership, and the ability to resolve and simplify complex business processes and servicing challenges. This person will be a highly self-motivated team-leader who is a strong communicator, has exceptional customer service orientation and is an analytical problem-solver! Core Job Duties - Establish an enterprise-wide data integration, data storage and data management vision & strategy. - Establish an enterprise systems integration team to automate and integrate enterprise systems & applications across organizations and business processes, including HR, Finance, Operations and HR. - Adopt internal delivery methodologies (ITIL, Agile, Kanban) with measured success criteria to deliver continuous, iterative value. - Lead efforts to mature and evolve the technology servicing (ITSM) capabilities across the company via a distributed service-desk and production operations team. - Lead cross-functional initiatives that align with cultural and business objectives to improve employee productivity and satisfaction. - Adopt ITIL / ITSM best practices for improved support & servicing. - Develop and document processes, policies and guidelines in support of the effective execution of product features. - Rationalize redundant tool investments & define investment & cost reduction strategies. - Recommend and implement tools that align with isolved's modern data strategy. Qualifications - Background working with a variety of technologies and data management systems. - Strong project management, computer, proofreading, research and organizational skills. - Proficient in Microsoft Word, Excel, PowerPoint and Outlook. - Experienced with Agile/Kanban methodologies. - Ability to work professionally and independently on assigned tasks and to complete assignments in a timely manner with great attention to detail. - Strong writing and verbal communication skills. - Ability to effectively communicate with corporate c-level, vendors and all levels of staff. - Process focused with experience and expertise in delivery and maturity methodologies. - Proficiency at creating technical documentation for projects and procedures utilizing Microsoft collaboration tools. - Highly organized with the ability to manage multiple projects. - Knowledge of computer hardware, including PC, Laptops and printers. - Ability to articulate technical problems to both customer as well as adjacent technical teams in written and verbal forms. - Working knowledge of a range of diagnostic utilities. - Strong documentation skills. Benefits - Visit www.isolvedhcm.com/careers for more information regarding our incredible culture and focus on our employee experience. - Visit www.isolvedeebenefits.com for a comprehensive list of our employee total rewards offerings. EEO Statement isolved is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. isolved is a progressive and open-minded meritocracy. If you are smart and good at what you do, come as you are. Disability Accommodation Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions outlined above.

Role Description The Public Policy and Government Affairs team seeks an intern to assist with research and writing in support of the team’s advocacy efforts and the HealthEquity mission more broadly. The intern will conduct research in the healthcare policy space, analyze and report on findings. The intern will also assist with other PPGA projects as assigned. - Conduct Policy Research: Support the public policy and government affairs team by researching federal and state legislation, regulatory proposals, and agency guidance related to Health Savings Accounts (HSAs), consumer-directed health plans, tax policy, and healthcare affordability. - Analyze and Summarize Findings: Prepare clear and concise research summaries, policy briefs, and memos that explain potential impacts on HSAs, account holders, employers, and the broader consumer-directed benefits industry. - Support Advocacy Materials: Assist in developing talking points, backgrounders, one-pagers, and briefing materials that communicate the organization’s positions to policymakers, industry partners, and coalition stakeholders. - Assist with Stakeholder Engagement: Help prepare materials for meetings with congressional offices, agency staff, trade associations, and coalition partners. Participate in virtual briefings when appropriate and document key takeaways. - Support Research Projects: Conduct qualitative and quantitative research on HSA utilization trends, demographic insights, tax impacts, employer adoption, and policy scenarios. Compile data, review external reports, and contribute to impact assessments for proposed legislative or regulatory changes. - Provide Administrative and Organizational Support: Assist with scheduling, meeting preparation, data entry, legislative trackers, and document management to support the government affairs workflow. - Contribute to Special Projects: Support cross-functional initiatives, public policy campaigns, industry events, and other assignments that advance the organization’s government affairs and advocacy objectives. Qualifications - Currently pursuing or recently completed a degree in public policy, political science, government, law, communications, economics or related field. - Coursework or academic projects focused on healthcare policy, tax policy, or regulatory affairs preferred. - Experience working with legislative tracking tools, databases, or CRM systems preferred. - Prior involvement in student government, campaigns, advocacy organizations, or public service a plus. - Strong interest in public policy, government processes, healthcare policy, and consumer-directed benefits. Requirements - Excellent research, writing, and analytical skills. - Ability to translate complex information into clear, actionable insights. - Strong attention to detail and organizational skills, and the ability to manage multiple tasks simultaneously. - Comfort working independently and collaboratively in a fast-paced environment. - Basic understanding or willingness to learn about Health Savings Accounts (HSAs), employer sponsored benefits, and federal regulatory agencies (e.g., IRS, Treasury, DOL). Benefits - Participate in wellness activities. - Receive a movement money stipend. - Participate in our Purple with Purpose program where you are paid to volunteer hours working with a local organization of your choice.