Talent.com
Assistant Director, Accreditation and Regulatory Affairs

Assistant Director, Accreditation and Regulatory Affairs

Duke UniversityDurham, NC, US
30+ days ago
Job type
  • Full-time
Job description

Assistant Director, Accreditation and Regulatory Affairs

The Assistant Director, Accreditation and Regulatory is responsible for leading system accreditation and regulatory programs at Duke University Health System (DUHS). This role involves collaboration with leadership, staff, and medical staff to ensure compliance with accreditation, regulatory, and disease-specific certification requirements.

This role requires a systems thinker with strong experience in policy management, including the use of policy management software and the ability to train others on its use. The Assistant Director will be responsible for supporting and enforcing use of the designated policy platform, ensuring policies are developed, maintained, and approved through the appropriate governance channels. This includes engaging leaders and stakeholders to gain buy-in for standardized policy processes and ensuring consistent adoption of the system's governance and committee review framework.

The Assistant Director also brings expertise in regulatory standards and improvement methodologies and promotes cross-entity collaboration to align priorities, elevate system-wide effectiveness, and ensure a consistent approach to policy management and compliance.

Key responsibilities include :

  • Interpretation and application of regulatory and accreditation standards
  • Oversight of policy and document management infrastructure
  • Stakeholder education and communication
  • Enforcement of policy governance processes, including committee approvals and software utilization

Continuous Readiness Efforts :

  • Lead the entity in evaluating, planning, and supporting continuous compliance and readiness infrastructure.
  • Oversee pre-survey, on-site survey, and post-survey activities for accreditation, regulatory, and certification programs.
  • Collaborate with leaders and departments to assess policies, evaluate workflows, and observe clinical care to identify gaps and ensure compliance.
  • Partner with Patient Safety, Quality, Professional Practice, Risk Management, Legal, and other departments to assess regulatory functions and maintain compliance.
  • Conduct ongoing monitoring, measurement, and analysis of survey data and trends; communicate results to appropriate departments and leadership.
  • Develop and maintain a comprehensive accreditation project plan.
  • Resource Development and Management :

  • Create and maintain toolkits, educational resources, and reference materials to support readiness.
  • Deliver training and presentations related to regulatory, accreditation, and certification requirements.
  • Ensure regulatory resources are up to date and communicate changes to leadership and staff.
  • Collaborate with clinical and administrative departments to implement changes that enhance compliance and improve patient outcomes.
  • Survey Coordination :

  • Serve as the primary liaison between accreditation / regulatory bodies and the entity.
  • Develop, maintain, and implement an entity-specific unannounced survey plan.
  • Manage on-site surveys, including communications, agendas, and logistics.
  • Support the development and execution of corrective action plans in response to survey findings.
  • Oversee reporting requirements for state and federal regulatory agencies.
  • Program Management :

  • Manage the accreditation and certification budget plan.
  • Develop and manage Accreditation Readiness Committee meetings and activities.
  • Monitor changes in federal and state regulations and accreditation standards; communicate updates to leadership and staff.
  • Enhance continuous improvement activities by teaching performance and process improvement methodologies.
  • Champion cross-entity collaboration to align priorities and standardize practices across the health system.
  • Knowledge, Skills, and Abilities :

  • Highly self-motivated and independent thinker with sound judgment.
  • Knowledge of accrediting organization standards and regulatory compliance.
  • Strong problem-solving, analytical, and negotiation skills.
  • Ability to prioritize and accomplish goals effectively.
  • Excellent interpersonal, facilitation, coaching, written, and verbal communication skills.
  • Flexible and adaptable to changing processes and procedures.
  • Experience working in complex organizations with multiple stakeholders.
  • Demonstrated ability to manage conflict, mentor teams, and recognize behaviors that contribute to success.
  • Minimum Qualifications :

  • Education : Bachelor's degree in Nursing, Business, Healthcare Administration, or a related field. Master's degree preferred.
  • Experience : Minimum of 7 years of experience in accreditation, certification, quality, risk management, patient safety, or clinical operations. Knowledge of quality improvement methodologies, project management, and regulatory standards (CMS, TJC, DNV, TJC, JACO, DHHS, DHSR, DOH). Experience with auditing, data analytics, staff training, and creative problem-solving preferred. Must be able to work on-site to ensure readiness for unannounced surveys. Preferred : Management experience in clinical operations, project management systems, and accreditation readiness.
  • Licensure / Certifications : RN or other clinical professional licensure preferred. Preferred certifications : CPHQ, Certified Quality Technician (ASQ), HACP, or CSHA.
  • Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy related conditions), sexual orientation, or military status.

    Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideasan exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

    Essential Physical Job Functions : Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and / or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

    Create a job alert for this search

    Director Regulatory • Durham, NC, US

    Related jobs
    • Promoted
    Program Manager, Accreditation and Regulatory

    Program Manager, Accreditation and Regulatory

    Duke UniversityDurham, NC, US
    Full-time
    Program Manager, Accreditation and Regulatory.The Accreditation and Regulatory Program Manager is responsible for collaborating, at a system / entity level at Duke University Hospital and Duke Raleig...Show moreLast updated: 30+ days ago
    • Promoted
    Regulatory Affairs Manager

    Regulatory Affairs Manager

    Katalyst Healthcares & Life SciencesRaleigh, NC, US
    Full-time
    Responsibilities : In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensu...Show moreLast updated: 3 days ago
    • Promoted
    Travel Physical Therapy Assistant (PTA) - $1,490 per week in Oxford, NC

    Travel Physical Therapy Assistant (PTA) - $1,490 per week in Oxford, NC

    AlliedTravelCareersOxford, NC, US
    Full-time
    AlliedTravelCareers is working with Windsor Healthcare Recruitment Group, Inc.Physical Therapy Assistant (PTA) in Oxford, North Carolina, 27565!. PTA needed for 13 week contract.Specialty Type : Reha...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Regulatory Associate

    Senior Regulatory Associate

    Invenia GroupRaleigh, NC, US
    Full-time
    Invenia Group has partnered with a fast-growing BioPharma company, looking to hire a Senior Associate, Regulatory to play a critical role in ensuring compliance with global regulatory requirements ...Show moreLast updated: 2 days ago
    • Promoted
    Assistant Research Director, Margolis Institute for Health Policy - Hybrid, Durham NC

    Assistant Research Director, Margolis Institute for Health Policy - Hybrid, Durham NC

    Duke Clinical Research InstituteDurham, NC, United States
    Full-time
    Duke University was created in 1924 through an indenture of trust by James Buchanan Duke.Today, Duke is regarded as one of America's leading research universities. Located in Durham, North Carolina,...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Interim Nurse Director, Extended Care Unit

    Travel Interim Nurse Director, Extended Care Unit

    GLC On-The-GoRoxboro, NC, US
    Temporary
    GLC On-The-Go is seeking a travel nurse RN Long Term Care (LTC) Manager, Long Term Care for a travel nursing job in Roxboro, North Carolina. Job Description & Requirements.Pay package is based o...Show moreLast updated: 2 days ago
    • Promoted
    Sr Regulatory Affairs Specialist

    Sr Regulatory Affairs Specialist

    TeleflexRaleigh, NC, US
    Full-time
    Sr Regulatory Affairs Specialist.Teleflex is investing in our capability to drive material cost improvement opportunities as part of a strategic corporate approach to reversing recent trends in cos...Show moreLast updated: 30+ days ago
    VP, Regulatory Affairs | REMOTE

    VP, Regulatory Affairs | REMOTE

    Implaion RecruitingDurham, North Carolina, United States
    Remote
    Full-time
    Quick Apply
    Vice President, Regulatory Affairs | REMOTE | Pre-IPO.Directly oversaw, or significantly contributed to, 2+ successful NDAs. Significant post-approval experience.Inspection readiness - labeling.Nimb...Show moreLast updated: 2 days ago
    • Promoted
    Assistant Director, Partnerships, DCA

    Assistant Director, Partnerships, DCA

    Duke Clinical Research InstituteDurham, NC, United States
    Full-time
    The Assistant Director for Partnerships is a member of the team at the Duke Center for Community-Engaged Scholarship, which is an interdisciplinary hub facilitating collaborative scholarship betwee...Show moreLast updated: 4 days ago
    Assoc. Dir / Director – US Regulatory Advertising & Promotion Job at TG Therapeuti

    Assoc. Dir / Director – US Regulatory Advertising & Promotion Job at TG Therapeuti

    MediabistroRaleigh, NC, United States
    Full-time
    JOIN US Open Position Title : Associate Director / Director – US Regulatory Advertising and Promotion Location : Remote (preference for East Coast time zone) If you are interested in the below posi...Show moreLast updated: 30+ days ago
    • Promoted
    Assistant Director, Accreditation and Regulatory Affairs

    Assistant Director, Accreditation and Regulatory Affairs

    Duke Clinical Research InstituteDurham, NC, United States
    Full-time
    At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and disc...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Physical Therapy Assistant - $1533 / Week

    Travel Physical Therapy Assistant - $1533 / Week

    Medpro Healthcare StaffingOxford, NC, US
    Full-time
    Medpro Healthcare Staffing is seeking an experienced Physical Therapy Assistant for an exciting Travel Allied job in Oxford, NC. Shift : 3x12 hr days Start Date : 10 / 20 / 2025 Duration : 13 weeks Pay : $1...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Director Regulatory Affairs

    Senior Director Regulatory Affairs

    Invenia GroupRaleigh, NC, US
    Full-time
    Invenia Group has partnered with a fast-growing BioPharma company, looking to hire a Senior Director, Regulatory responsible for leading regulatory strategy, development, and execution across the c...Show moreLast updated: 2 days ago
    • Promoted
    Associate Regulatory Affairs Manager

    Associate Regulatory Affairs Manager

    Katalyst Healthcares & Life SciencesRaleigh, NC, US
    Full-time
    Associate Regulatory Affairs Manager.Responsibilities : The Associate Regulatory Affairs Manager will support the development, review, and submission of regulatory documents for medical device and I...Show moreLast updated: 30+ days ago
    • Promoted
    Sr Regulatory Affairs Strategy Specialist

    Sr Regulatory Affairs Strategy Specialist

    Becton DickinsonDurham, NC, US
    Full-time
    Senior Regulatory Affairs Strategy Specialist.BD is one of the largest global medical technology companies in the world.Advancing the world of health is our Purpose, and it's no small feat.It takes...Show moreLast updated: 30+ days ago
    • Promoted
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    TeleflexRaleigh, NC, US
    Full-time
    The Regulatory Affairs Specialist will develop strategies and submissions for projects and issues related to regulatory documents, global submissions, investigations, product development planning, ...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Staff Regulatory Affairs Associate # 4333

    Senior Staff Regulatory Affairs Associate # 4333

    GrailDurham, NC, US
    Full-time
    Senior Staff Regulatory Affairs Associate # 4333.GRAIL is a healthcare company, pioneering new technologies to advance early cancer detection. We are using the power of next-generation sequencing (N...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Family Law Attorney

    Senior Family Law Attorney

    JobotWake Forest, NC, US
    Full-time +1
    Hybrid + Quarterly Bonuses + 401k Match and more!.This Jobot Job is hosted by : Katie Griffith.Are you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume.Sa...Show moreLast updated: 22 days ago