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Regulatory affairs manager Jobs in San Francisco, CA
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Regulatory Affairs Manager
Alameda Health SystemOAKLAND, CA, United States- Promoted
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UC San DiegoOakland, CA, United States- Promoted
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VirtualVocationsOakland, California, United States- Promoted
Regulatory Affairs Director
Rigel PharmaceuticalSouth San Francisco, CA, USSenior Manager, Regulatory Affairs
R&D PartnersCalifornia, CA- Promoted
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Randstad Life Sciences USSan Francisco, CA, US- Promoted
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Kyverna TherapeuticsEmeryville, CA, US- Promoted
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Maze TherapeuticsSouth San Francisco, California, United StatesRegulatory Affairs
Katalyst HealthCares & Life SciencesOakland, CA- Promoted
Regulatory Affairs Manager
SimplyApplyOakland, CA, United StatesRegulatory Affairs Manager
Alameda Health SystemOAKLAND, CA, United States- Part-time
Summary
SUMMARY : Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Joint Commission (JC), California Department of Public Health (CDPH), CMS, OSHPD, CDPH Lab Field Services, CDPH Radiologic Health Branch, etc.; prioritizes projects, coordinates action plans, and monitors / analyzes results for accreditation projects, consistent with the organization's strategic goals.
DUTIES & ESSENTIAL JOB FUNCTIONS : NOTE : Following are the duties performed by employees in this classification. However, employees may perform other related duties at an equivalent level. Not all duties listed are necessarily performed by each individual in the classification.
1. Actively coordinates the organization’s readiness rounds program and is primarily responsible for the development, communication, implementation and tracking of action plans necessary to close identified gaps in care or compliance with The Joint - Commission (TJC) standards and Centers for Medicare and Medicaid Services (CMS) and Title 22 regulations.
2. Assists in all accreditation and regulatory activities, including surveys, survey preparation and readiness assessments.
3. Develops comprehensive accreditation work plans by establishing deliverables, accountabilities, and timelines.
4. Finalizes corrective action responses to The Joint Commission and other regulatory agencies for survey and for-cause and compliant investigations.
5. Identifies growth and areas of opportunity to enhance Regulatory Affairs and AHS initiatives.
6. Identifies regulatory vulnerabilities and determines escalation level if necessary.
7. Maintains and implements department unannounced survey plans.
8. Manages communications, agendas, and logistics for onsite survey activities.
9. Manages onsite accreditation and regulatory surveys; supports command center activities.
10. Performs other duties as assigned.
11. Provides guidance on Joint Commission standards interpretation and other regulatory requirements as they apply to organizational practice / performance.
12. Serves as contact and point person for Joint Commission accreditation manuals, standards-related publications and newsletters and educational materials; distributes pertinent information.
MINIMUM QUALIFICATIONS :
Any combination of education and experience that would likely provide the required knowledge, skills and abilities as well as possession of any required licenses or certifications is qualifying.
Preferred Education : Master’s degree in a healthcare related field.
Preferred Licenses / Certifications : Certified as a Professional Healthcare Quality (CPHQ) or Certified as a 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 / patient safety in healthcare; experience applying quality assurance / performance improvement (QAPI) and customer service approaches; experience with Midas, Epic / Electronic Health Record (EHR), County Health Systems, OSHPD.
Quality
Regulatory Affairs
Services As Needed / Per Diem
Varies
Business Professional & IT
FTE : 0.01