Product Compliance Analyst II (Product Quality Compliance Specialist II) - Remote
Net Health
- Pittsburgh, PA
- Permanent
- Full-time
A high-growth and profitable company, we help caregivers harness data for human health. We also honor and respect the needs of our Net Health family and staff, which is why we offer a work-from-anywhere environment and unlimited PTO. Our welcoming and collaborative culture paired with progressive benefits makes Net Health the ultimate career home!
As a leading-edge SaaS company in healthcare, we deliver solutions that help patients get better, faster, and live more fulfilling lives. Our software and predictive analytics cover the continuum of care, from hospital-to-home, across various medical specialties. Come join us and start the next chapter of your exciting career while helping others to live better lives.World-Class Benefits That Reflect Our World-Class Culture.Click Here to Learn More!:#WorkFromAnywhere #UnlimitedPTO #ComprehensiveBenefitsPackage #EmployeeResourceGroups #CasualDressCode #PrioritizedEmployeeWellness #DiversityAndInclusion #AVoice #NewHireSupport #CareerDevelopment #EducationalAssistance #EmployeeReferralBonus #ProgressiveParentalLeaveJOB OVERVIEWMaintains the organization's ongoing relationships with regulatory commissions/authorities. Coordinates and conducts the assessment of internal controls to ensure compliance as required by regulatory commissions/authorities. Develops programs and processes to manage complaint cases brought to regulatory authorities and develops process improvements to avoid future complaints. Advances organization positions with internal and external parties. Prepares and sponsors testimony to governmental or regulatory agencies.Ensure the organization's compliance with applicable laws regulating their industry (e.g., government, energy, financial services, manufacturing, healthcare). Review organization's business practices to ensure pertinent regulations are followed, identify areas of non-compliance, and create a plan to implement changes as needed. Maintain a deep knowledge of regulations and stay abreast of all regulatory changes relevant to industry and organization. Review marketing materials to ensure they do not violate truth in advertising or ethics laws. Assist in the development of compliance training programs.RESPONSIBILITIES AND DUTIES
- Raise and maintain product compliance awareness to development/product team key stakeholders
- Understand regulatory governing bodies and product requirements such as the CMS (legal medical record: authentication; authorship integrity), Joint Commission Standards (or like non-profit healthcare accrediting organizations.), OIG, and OCR.
- Ability to demonstrate thorough understanding of compliance related projects (governing requirements) to full product execution with all key stakeholders.
- Will act as a SME key decision maker with product/development team members in order to ensure compliance requirements are being met during the refinement process through release readiness.
- Articulate the value add to all related compliance projects that will resonate with our internal team stakeholders and customers
- Ensure awareness and operational adherence to compliance-related product changes that impact patient safety, coding and billing, and/or other regulatory governing topics.
- Support a proactive approach toward investigation and resolving potential product compliance issues
- Understand and identify when compliance related topics may require additional support/investigation
- Educate and inform all collaborative teams when specific features require additional research and scrutiny to adhere with compliance best practices
- Support key information with prioritizing compliance stories, defects, and requirements in the shared backlog related to compliance.
- Explore and attend employee development opportunities to enhance knowledge base regarding compliance topics such as coding/billing, CMS, Legal Medical Record, OIG, NHPCO, etc.,)
- Actively utilize available resources by reviewing following updates/newsfeeds regarding compliance topics that may impact the product (technical updates, etc.,)
- Establish and maintain regulatory policies with particular emphasis on compliance with the Quality Management System, and relevant Medical Device Directives and Regulations (e.g., ISO 13485).
- Maintain existing device certifications (FDA Class I medical device, CE Mark, WAND)
- Manage preparation for all regulatory body audits
- Work across departments to achieve goals relative to regulatory compliance, including working with product development, HR, legal, and security
- Manage and maintain the quality systems and any other quality-related activity
- Provide regulatory guidance to product development team
- Monitor global regulatory developments affecting products and communicate significant issues to management
- Develop and implement all training required for regulatory compliance, including requirements related to device quality, defect reporting and communication of client requirements
- Serve as point of contact for certification bodies and escalated client complaints
- Identify and suggest solutions to regulatory tasks
- Collaborate with consultants to prepare document packages for new device applications (FDA De Novo, MDSAP)
- Report on QMS performance to ensure that quality objectives are met
- Bachelor’s degree in nursing, law, healthcare administration or a related field of study
- 4+ years of experience working within healthcare compliance required
- Ability to read, understand, and interpret regulatory rules and requirements for a variety of audiences
- Experience in risk management or regulatory audit in the health care space, preferred
- Highly analytical with strong attention to detail
- Outstanding written and verbal communication skills required (including the ability to express oneself effectively within groups and in one-to-one conversations)
- Conveys information clearly and effectively in written and oral communication
- Legal and/or compliance certification(s) preferred, i.e., (HCCA, IAPP, etc.)
- Experience working in an entrepreneurial, fast-paced company
- Self-directed and solution oriented
- Maintain a high level of work effort consistency and follow through with all projects
- Microsoft Word, Excel, Outlook, PowerPoint