Regulatory Affairs Manager

5+ years

Not Disclosed

Oakland

10 March 4, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Affairs Manager
Location: Oakland, CA
Category: Quality, Regulatory Affairs
Job Type: Services As Needed / Per Diem - Varies
Job Group: Business Professional & IT
Req #: 41481-30697
FTE: 0.01
Posted: February 28, 2025

Summary:

Plans, coordinates, and monitors compliance with federal, state, and local regulations. Manages accreditation activities necessary for maintaining required accreditation and ensures compliance with certifications and licensure requirements from organizations such as Joint Commission (JC), California Department of Public Health (CDPH), CMS, OSHPD, CDPH Lab Field Services, and CDPH Radiologic Health Branch. Prioritizes projects, coordinates action plans, and monitors/analyzes results for accreditation projects in alignment with the organization's strategic goals.

Duties & Essential Job Functions:

Note: The following duties are performed by employees in this classification. Employees may perform other related duties at an equivalent level. Not all duties listed are necessarily performed by each individual in the classification.

Coordinates the organization’s readiness rounds program, developing, communicating, implementing, and tracking action plans to address gaps in care or compliance with The Joint Commission (TJC) standards, CMS, and Title 22 regulations.
Assists in accreditation and regulatory activities, including surveys, survey preparation, and readiness assessments.
Develops comprehensive accreditation work plans by establishing deliverables, accountabilities, and timelines.
Finalizes corrective action responses to The Joint Commission and other regulatory agencies for survey and for-cause and complaint investigations.
Identifies growth opportunities and areas for enhancement within Regulatory Affairs and AHS initiatives.
Identifies regulatory vulnerabilities and determines escalation levels as necessary.
Maintains and implements department unannounced survey plans.
Manages communications, agendas, and logistics for onsite survey activities.
Oversees onsite accreditation and regulatory surveys and supports command center activities.
Performs other duties as assigned.
Provides guidance on Joint Commission standards interpretation and other regulatory requirements as they apply to organizational practice and performance.
Serves as a contact point for Joint Commission accreditation manuals, standards-related publications, newsletters, and educational materials, distributing pertinent information as necessary.

Minimum Qualifications:

Any combination of education and experience that would likely provide the required knowledge, skills, and abilities, along with possession of any required licenses or certifications, is qualifying.

Preferred Education: Master’s degree in a healthcare-related field.
Preferred Licenses/Certifications: Certified Professional in Healthcare Quality (CPHQ) or Certified Joint Commission Professional (CJCP); LEAN/Six Sigma Certification.
Required Education: Bachelor’s degree in nursing or healthcare-related field.
Required Experience: Five years of hospital operations or patient care experience; two years in accreditation, licensing, regulatory compliance, quality, performance improvement, or patient safety in healthcare. Experience in applying quality assurance/performance improvement (QAPI) and customer service approaches. Familiarity with Midas, Epic/Electronic Health Record (EHR), County Health Systems, and OSHPD.

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Regulatory Affairs Manager

Job Description

Summary:

Duties & Essential Job Functions:

Minimum Qualifications:

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