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Regulatory Compliance Specialist

1 month ago

Minneapolis, United States LifeSource Full time

Description

LifeSource is hiring a Regulatory Compliance Specialist to be responsible for the awareness, execution, and accountability of regulatory requirements for donation and transplantation medical charts. Coordinate the organization's audit program and audit schedule via the organization's established Quality Management System (QMS) software, including audit checklist and report development.

As a Regulatory Compliance Specialist, you'll advance our life-saving work by performing the following job duties:

  • Compliance Audit: Develop, coordinate, and facilitate compliance audits to verify execution and effectiveness of processes and procedures to meet internal compliance, accreditation, or regulatory standards.

  • Data Submission Verification: Perform verification of time-sensitive data submissions on assigned donor records to ensure accuracy and adherence to regulatory reporting and quality service requirements.

  • Donor Inquiries, Process Deviations, and Patient Safety: Coordinate appropriate communication and follow through with applicable regulatory and donation agencies related to process inquiries, deviations, and patient safety concerns.

This includes:

  • Executing ongoing, timely audit of assigned donor records to ensure accuracy of regulatory compliance and quality service delivery of required data reporting.
  • Collaborating with appropriate leaders to schedule and prioritize audits and assess audit outcomes to determine any needed changes to ensure ongoing regulatory compliance.
  • Assessing donor record and data submission compliance against internal and external requirements.
  • Facilitating and investigating defined donor inquiries and preparing responses for leadership review and submission.
  • Coordinating appropriate communication and follow through with regulatory and donation agencies relating to process inquiries, deviations, and applicable patient safety documentation.
  • Monitoring changes to regulatory and accreditation requirements and notify appropriate leaders via a systematic and timely process.
  • Developing and maintaining an understanding of current and proposed regulations applicable to organ, tissue, and eye donation.

Work schedule: 1.0 FTE, work hours primarily Monday-Friday between the hours of 8:00am - 5:00pm. This role is on-site in Minneapolis.

Position Requirements

QUALIFICATIONS

  • Requires a combination of education and experience equivalent to seven years of healthcare, clinical or regulatory environment experience.
  • Knowledge or competency in organ procurement and OPTN regulations strongly preferred.
  • Experience with regulatory audits, data submission, and scheduling.
  • Strong working knowledge of Microsoft Office applications, QMS and regulatory software.
  • Self-directed, motivated contributor with ability to function autonomously, manage multiple projects simultaneously, set priorities, execute timely follow through and meet deadlines.
  • Strong communication and interpersonal skills, effective at establishing rapport and working relationships with leaders, peers, and vendors.
  • Detail oriented and highly organized with a desire to improve processes, take initiative and solve problems.
  • Excellent critical thinking and analytical skills to confidently execute reasonable and sound decision making.
  • Demonstrated ability to exhibit a high degree of quality, integrity, and honor confidentiality of appropriate information including, but not limited to, personal team member data, organizational operations or work processes, donor and donor family information, contributor details, any financial information and medical or protected health information (PHI) in accordance with HIPAA.

Why Join LifeSource:

Since 1989, the LifeSource team has worked with our regions' diverse communities to break down barriers to donation. Bringing a rich diversity of perspectives and experience to our organization at all levels strengthens our ability to serve our community and fulfill our mission. Our values embody how we engage in our work - respect, advocacy, accountability, life and innovation. More information on our continued work toward diversity, equity, and inclusion can be found on our website.

We set our team up for success by providing comprehensive on-boarding, as well as on-going personal and career development. Team members are offered traditional benefits such as health, vision, dental, and life insurance, generous PTO, and 401k matching. We also support our team through non-traditional benefits such as tuition reimbursement, resiliency coaching, and HSA employer contributions.

LifeSource is committed to creating a diverse, inclusive and welcoming workplace with opportunities for all talent to thrive. We are an equal opportunity employer and strongly encourage BIPOC, LGBTQIA+, veterans, persons with disabilities, members of marginalized communities, and non-traditional applicants to apply.

This position will remain open for 30 days or until filled; however, applicants are encouraged to submit their applications as soon as possible as the review process will begin right away.

Shift

Days

Exempt/Non-Exempt

Exempt

Full-Time/Part-Time

Full-Time

Location

Minneapolis, MN - LifeSource

Open Date

7/10/2024

EOE Statement

LifeSource is committed to creating a diverse, inclusive and welcoming workplace with opportunities for all talent to thrive. We are an equal opportunity employer and strongly encourage BIPOC, LGBTQIA+, veterans, persons with disabilities, members of marginalized communities, and non-traditional applicants to apply. PDN-9c7e68aa-6eca-4677-94dd-1d3ee8346dcd