Regulatory Project Manager

2 months ago

Atlanta, United States Azalea Health Innovations Inc Full time
Job DescriptionJob Description

IN SUMMARY...

The Regulatory Project Manager main function is to ensure that Azalea products empower hospitals and clinics to qualify for, fully participate in, and receive maximum reimbursements from all relevant regulatory programs. The role works closely with all teams in prioritizing, designing, testing, and completing 3rd-party certification for the regulatory-related features of both our ambulatory and hospital products.

WHAT YOU WILL DO...

  • Act as clinical regulatory subject matter expert; familiarity with regulatory requirements outlined by CMS Conditions of Participation, CCHIT, Clinical Quality Measures, Promoting Interoperability, Improvement Activities, JCAHO/HBIPS, USCDI, Cures Act, Real World Testing, Acceptable Use Criteria, etc.
  • Research at the deepest level (independently find and verify the correct sources and documents) regulatory requirements and translate them into concrete action steps that Azalea needs to take, and explain why
  • Document in detail the problems that need to be solved in order to maintain compliance, along with critical timeline dates
  • Document the business impact of each regulatory program and empower the Product Managers to quickly and confidently prioritize work
  • Work in conjunction with the Engineering team to project manage regulatory features being added to the software
  • Work in conjunction with our regulatory auditor, Drummond, to project-manage the necessary certifications, product tests, and attestations.
  • Collect and promptly file all required documentation with our auditor
  • Provide timely documentation to Product Marketing so that our employees, clients, and prospects are well-informed about Azalea's compliance position and how it relates to them.
  • Using user behavior data as well as over-the-shoulder observation and client interviews, analyze the ways in which our clients are using our products from a regulatory perspective, and identify problems for which a solution could lead to better business outcomes.
  • Work in conjunction with the Engineering team to help identify, duplicate, and resolve bugs in a timely manner
  • Scope and prioritize regulatory activities based on business and customer impact in conjunction with Product Managers
  • Clearly communicate product functionality and benefits to Azalea and client users with new feature write ups and videos
  • Support the development of strategic regulatory projects to ensure that all important use cases are handled in the delivered software and working as planned
  • Maintain product regulatory consistency throughout product cycle, to include regulatory design, testing, and delivery
  • Implement ongoing regulatory improvement processes working with interdepartmental teams
  • Provide effective communication regarding regulatory issues, objectives, initiatives and performance to plan
  • Anticipate product release problems and takes corrective action, escalating as needed, to resolve and achieve commitments
  • Assist Support team in troubleshooting as needed to effectively report all issues to the engineering team to ensure fastest resolution.
  • Provide escalated help to the support team if product documentation is insufficient for support to address the question independently
  • Empower support to be self-sufficient by updating documentation with each question that is escalated to product.
  • Assist all departments as necessary on any software related functionality, feedback, or issues.

BACKGROUND AND SKILLS YOU WILL BRING...

  • BS/BA degree required
  • Minimum of 4 years of relevant clinical regulatory experience
  • Exposure to clinical regulatory, nursing, pharmacy, lab or other core clinical roles
  • Experience analyzing clinical regulatory requirements will be considered a plus
  • Experience with clinical EMR/EHR solutions that include clinical regulatory and financial solutions will be considered a plus
  • Excellent written and verbal technical and communication skills
  • Excellent computer and internet skills/instincts, including strong proficiency in web-based applications
  • Solid technical background with understanding and/or hands-on experience in software development and web technologies
  • Strong problem solving skills and willingness to roll up one's sleeves to get the job
  • Skilled at working effectively with cross functional teams in a matrix organization

SUCCESS LOOKS LIKE...

  • Being aggressive and taking initiative; we trust you to move the needle forward
  • Doing the job; outcomes are just as important as strategy
  • Being adaptable and amenable to meet the changes of a dynamic and evolving industry
  • Demonstrating humility; partnership and collaboration is who we are and how we operate
  • Tapping into your innovative side; conventional is not always correct

HOW WE INVEST IN YOU...

  • Competitive and comprehensive benefits: Coverage options to support the whole person, including full medical, dental, vision, and life insurance
    • Generous employer sponsored subsidy towards employee's medical insurance premiums
    • Azalea Health covers 100% of the premiums for Life AD&D and Long-Term Disability for all eligible full-time employees
  • Balance and flexibility: Simple Paid Time Off (PTO) options. You earn your time, use it as you choose.
  • Economic opportunity: Competitive total rewards package that offers competitive pay and advancement opportunities

Azalea Health's EEO Statement

Azalea Health is an Equal Opportunity Employer committed to creating a diverse and inclusive workforce where our employees excel based on merit, qualifications, knowledge, ability, and job performance. We embrace and encourage our employees' differences in age, color, disability, ethnicity, gender identity or expression, language, national origin, physical and mental ability, political affiliation, race, religion, sexual orientation, socioeconomic status, veteran status, and any other characteristics protected by federal, state, and local laws that make our employees unique.

  • Lead Manager, Regulatory Affairs Operations

    1 week ago

    Atlanta, Georgia, United States Takeda Pharmaceuticals Full time

    About the Position:As a Lead Manager in Regulatory Affairs Operations, you will play a pivotal role within the Vaccine Business Unit (VBU) to advance the mission of Regulatory Operations by facilitating health authority submissions, registrations, and archival processes, alongside managing Veeva RIM workflows and ensuring the accuracy of metadata in MEDIVA....

  • Manager, Complaints

    2 months ago

    Atlanta, United States Cetera Full time

    Cetera Financial Group is currently seeking a Compliance Manager to lead a team focused on Regulatory and Client Response. This is a unique opportunity to support the network of Cetera Financial Group broker/dealers and registered investment advisers with regulatory and customer complaint matters. This is a hybrid role, candidates must be near an office...

  • Regulatory Compliance Program Manager

    2 weeks ago

    Atlanta, Georgia, United States Block Full time

    Job OverviewCompany Overview:Block is a unified organization composed of various teams, all dedicated to the shared mission of economic empowerment. Our foundational teams — including People, Finance, Counsel, Hardware, Information Security, and Platform Infrastructure Engineering — offer essential support and guidance at the corporate level. These teams...

  • Regulatory Compliance Program Manager

    1 week ago

    Atlanta, Georgia, United States Block Full time

    Job OverviewCompany Overview:Block is a diverse organization unified by a common goal of fostering economic empowerment. Our foundational teams, including People, Finance, Counsel, Hardware, Information Security, and Platform Infrastructure Engineering, collaborate across various business sectors and global locations to create inclusive policies, manage...

  • Regulatory Coordinator

    3 months ago

    Atlanta, United States CorDx Full time

    Job DescriptionJob DescriptionCorDx, a thriving biotechnology company, is seeking a Regulatory Coordinator to join our team. In this role, you will assist in the planning and execution of regulatory compliance activities. You will analyze and interpret regulations and guidelines to ensure company compliance and organize necessary documentation. The ideal...

  • Regulatory Coordinator

    4 weeks ago

    Atlanta, United States CorDx Full time

    Job DescriptionJob DescriptionCorDx, a thriving biotechnology company, is seeking a Regulatory Coordinator to join our team. In this role, you will assist in the planning and execution of regulatory compliance activities. You will analyze and interpret regulations and guidelines to ensure company compliance and organize necessary documentation. The ideal...

  • Project Manager

    4 weeks ago

    Atlanta, United States WSN Full time

    MUST HAVE FINANCIAL SERVICES EXPERIENCE. NO THIRD PARTIES PLEASE.Job Overview:We are seeking an experienced and highly organized Project Manager to place in a role at one of our clients, a large bank in the Greater Atlanta, GA area. The Project Manager will be responsible for leading and managing projects across various business units within the bank,...

  • Project Manager

    4 weeks ago

    Atlanta, United States WSN Full time

    MUST HAVE FINANCIAL SERVICES EXPERIENCE. NO THIRD PARTIES PLEASE.Job Overview:We are seeking an experienced and highly organized Project Manager to place in a role at one of our clients, a large bank in the Greater Atlanta, GA area. The Project Manager will be responsible for leading and managing projects across various business units within the bank,...

  • Regulatory Compliance Program Manager

    2 weeks ago

    Atlanta, Georgia, United States Block Full time

    Job OverviewCompany OverviewBlock is a multifaceted organization dedicated to economic empowerment. Our foundational teams, including People, Finance, Counsel, Hardware, Information Security, and Platform Infrastructure Engineering, collaborate across various business units and global locations to create inclusive policies, forecast financial outcomes,...

  • Claims TPA Regulatory Governance and Performance Manager

    3 weeks ago

    Atlanta, United States AIG Full time

    At AIG, we are reimagining the way we help customers to manage risk. Join us as a Claims TPA Regulatory Governance and Performance Manager to play your part in that transformation. It’s an opportunity to grow your skills and experience as a valued member of the team. Make your mark in Claims Our Claims teams are the proven problem solvers of choice for...

  • Head of Regulatory Compliance

    2 weeks ago

    Atlanta, Georgia, United States augmentjobs Full time

    Position OverviewThe Head of Regulatory Compliance at Augmentjobs will play a pivotal role in directing the formulation and execution of regulatory frameworks, ensuring adherence to all relevant legislation, and fostering relationships with regulatory bodies. This position is essential for protecting the integrity of the company's operations and guaranteeing...

  • Regulatory Reporting Manager

    5 days ago

    Atlanta, United States Southern Company Full time

    Job Description: The Project Manager will lead the preparation of reports and filings made to the Public Service Commission (PSC) including: New generation project Semi-Annual Reports, monthly reports, data requests and preparation for future filings. Additionally, the project manager will work together with Georgia Power and Southern Company Accounting,...

  • Global Regulatory Lead

    2 months ago

    Atlanta, United States UCB Full time

     Make your mark for patientsWe are looking for a Global Regulatory Lead to join us in our Global Regulatory team, based in any of our Brussels (Belgium), Monheim (Germany), Slough (UK) or Atlanta or Raleigh (US) offices. About the roleThe Global Regulatory Affairs Leader provides regulatory leadership to assigned Mission and/or asset. ...

  • Complex Regulatory Analyst

    2 weeks ago

    Atlanta, Georgia, United States AIG - American International Group, Inc. Full time

    Position OverviewThis role is a hybrid position, requiring a minimum of three days per week in the office. As part of the Regulatory Reporting team, you will be responsible for managing complex projects that demand a high level of analytical skills and problem-solving abilities.Key ResponsibilitiesConduct in-depth analysis and reporting on regulatory...

  • Data Engineer

    3 months ago

    Atlanta, United States OneSource Regulatory Full time

    Job DescriptionJob DescriptionSalary: Company IntroductionOneSource Regulatory Technology hosts a number of innovative solutions to enhance job performance in the Pharmaceutical space.  OSR Technology is looking for an experienced and dedicated data engineer to join our product solutions team!  Job DescriptionOneSource Regulatory is trying to identify a...

  • Compliance Manager for Regulatory Affairs

    2 weeks ago

    Atlanta, Georgia, United States Channel Personnel Services Full time

    Job OverviewA prominent global organization is seeking a Regulatory Compliance Manager to join their team. This position is critical for ensuring adherence to chemical control and product-related regulations while advocating for legislative matters across the Americas. The successful candidate will coordinate activities with research, technology,...

  • Project Manager

    3 hours ago

    Atlanta, Georgia, United States AECOM Full time

    About the RoleAECOM is seeking a highly skilled Construction Manager to join our team in Atlanta, GA. As a key member of our construction team, you will be responsible for overseeing the day-to-day activities of construction projects, ensuring they are completed on time, within budget, and to the required quality standards.Key ResponsibilitiesProject...

  • Principal Regulatory Affairs Specialist

    3 weeks ago

    Atlanta, United States Accordance Search Group Full time

    Our client is looking for a Principal Regulatory Affairs Specialist to work on-site in Atlanta, GA. As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting...

  • Principal Regulatory Affairs Specialist

    1 week ago

    atlanta, United States Accordance Search Group Full time

    Our client is looking for a Principal Regulatory Affairs Specialist to work on-site in Atlanta, GA. As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting...

  • Principal Regulatory Affairs Specialist

    1 week ago

    atlanta, United States Accordance Search Group Full time

    Our client is looking for a Principal Regulatory Affairs Specialist to work on-site in Atlanta, GA. As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting...