Demo

Regulatory Affairs Program Manager

Vets2industry
Portland, OR Full Time
POSTED ON 3/19/2025
AVAILABLE BEFORE 4/18/2025

Department Overview

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OHSU is Oregon’s only public academic health center. We are a system of hospitals and clinics across Oregon and southwest Washington. We are an institution of higher learning, with schools of medicine, nursing, pharmacy, dentistry and public health – and with a network of campuses and partners throughout Oregon. We are a national research hub, with thousands of scientists developing lifesaving therapies and deeper understanding. We are a statewide economic engine and Portland’s largest employer. And as a public organization, we provide services for the most vulnerable Oregonians, and outreach to improve health in communities across the state.

This position is a key contributor to the Regulatory Affairs team, supporting the mission, goals, and objectives of OHSU Healthcare. Your key functions will include coordination of regulatory readiness, survey process, and follow-up activities, including corrective action plan oversight, production, and tracking of data / reports related to regulatory compliance and survey outcomes. You will be the System Administrator for one of two systems / software owned by Regulatory Affairs and the backup System Administrator for the other of the two. This position also provides support, consultation, and coaching to healthcare leaders to interpret regulatory standards and compliance needs. This position independently gathers, compiles, analyzes, and prepares qualitative and quantitative information and statistical data; provides complex systems support and presents information in narrative and schematic form for corrective action and performance improvement planning and decision making.

Function / Duties of Position

Management of Regulatory Affairs Systems and Software

  • Serves as the primary System Administrator for one of two systems / software managed by Regulatory Affairs, and back-up System Administrator for the other of the two.
  • The electronic regulatory compliance audit / rounding software.
  • The electronic healthcare policy management system for policies, procedures, forms, standard work, department Scope of Service documents or Nurse Staffing Plans, and any other applicable documents.

Management of Regulatory Accreditation, Certification, Survey Processes, and Survey Response / Follow-Up

  • Key member of RA team responsible for OHSU Healthcare’s ongoing applications for accreditation and certification to regulatory bodies. Manages ongoing updates to the application with regular communication with the OHSU Healthcare leadership.
  • Manages the survey process from regulatory agencies including but not limited to : planning and coordinating known surveys, oversight of unscheduled surveys related to health care accreditation and certification as well as responses to regulatory agencies for any subsequent corrective action plans and related objective evidence summaries.
  • Works with designated stakeholders, ensures that appropriate timelines are followed for survey completion, corrective action plan submission and objective evidence data reporting.
  • Develops reports and provides data / updates related to regulatory findings and corrective action plan oversight / management / completion, including communicating said information to OHSU leadership via a dashboard or other, regularly updated and easily accessible / shareable source.
  • Maintains a current Regulatory Calendar of all regulatory surveys, reviews, and activities as appropriate and prepares for posting / distribution.
  • Manages the maintenance of licenses, accreditations, certifications and CLIA licenses from regulatory bodies.
  • Manages the payment of invoices following regulatory accreditation, certification reviews, annual fees, intra-cycle reviews and on-site visits.
  • Required Qualifications

    Education :

  • A bachelor’s degree in Business Administration, Management, Public Administration, or a field directly related to the position will substitute for two years of the required experience.
  • Experience :

  • At least 3 years of experience with responsibility for program or project monitoring and coordination.
  • The experience must have included program evaluation responsibility.
  • Job Related Knowledge, Skills and Abilities (Competencies) :

  • Excellent communication skills to effectively interact with outside regulatory agencies and internal leaders.
  • Proficiency in office automation computer software including the Microsoft Office Suite of products and other various OHSU internal products.
  • Knowledge of healthcare regulatory agencies and standards.
  • Ability to understand laws, interpret laws and interpret standards for OHSU.
  • Ability to work independently, problem solve and decision making capabilities.
  • Sensitivity, tact, and discretion in dealing with highly confidential information and communication.
  • Ability to facilitate meetings and provide education as needed.
  • Preferred Qualifications

    Education :

  • Bachelor’s degree plus five years’ experience of below described experience.
  • Experience :

  • 7 to 10 years of experience administering or managing parts or subsets of a project or program within healthcare.
  • Interpreting program policies and other control documentation, writing and updating policy and other key documents and making recommendations for change.
  • 3 years of experience managing electronic database and other information reporting computer systems.
  • Working knowledge of website strategies.
  • 3 years of experience with healthcare accreditation and / or certification regulatory standards, surveys, or program administration.
  • Clinical experience.
  • Job Related Knowledge, Skills and Abilities (Competencies) :

  • Deep knowledge of NIAHO standards, CMS’ Conditions of Participation, and Oregon’s Administrative Rules.
  • Proficiency with various OHSU internal products.
  • Additional Details

  • Primary worksite is at MBS however, must be able to travel to all OHSU Healthcare sites.
  • All are welcome

    Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or aaeo@ohsu.edu.

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