Regulatory Affairs Manager jobs in Orlando, FL

Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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Regulatory and Accreditation Affairs Program Manager
  • NemoursCareerSite
  • Orlando, FL FULL_TIME
  • The Program Manager, Regulatory& Accreditation Affairs is responsible for leading the Nemours Children’s Health, Florida Regulatory and Accreditation program, and managing the respective team(s). The Program Manager's primary goal is to ensure that the Nemours Children’s Health, Florida (NCH-FL) remains compliant with all Federal, State and local regulatory requirements, and adheres to all identified accreditation and certification program standards. The Program Manager is expected to collaborate with the Director, Patient Care Services leaders, and others to craft a vision for a best-in-class program that ensures continuous survey readiness, proactive identification and response to emerging regulatory and enforcement trends, and the sustainability of process and culture around regulatory compliance. The Program Manager will be expected to operationalize that vision in partnership with other key stakeholders including nursing, medical and operational leadership. The Program Manager is expected to serve as a subject matter expert and resource, for the team(s) and committees, for the Q&S Department and for the organization as whole. The Program Manager will demonstrate exceptional critical thinking skills, develop a systematic approach to continuous compliance/readiness, lead and grow teams, and develop individual team members.

    Position Responsibilities

    • Additional miscellaneous duties and responsibilities, as may be assigned from time to time by employee’s supervisor.
    • Clinical Activities - Leads compliance with all applicable federal and state regulations.  Reviews accreditation compliance across the continuum of children’s care, which includes supporting the planning and implementation of standard clinical practices, protocols and clinical guidelines; documentation, monitoring care and outcomes of hospital patients.  Serves as an expert resource in accreditation/regulatory-compliance for clinical practice. 
    • Performance Improvement – Participates in clinical processes and outcomes and system reviews related to accreditation compliance. Advises and facilitates policy drafts and revisions for NCH-FL.  Supports the implementation of clinical practice guidelines; develops mechanisms for quality filters, audits, and case reviews; identify trends and helps outline remedial actions for accreditation or regulatory compliance while maintaining confidentiality. 
    • Administration - Manages the collection and reporting of data (operational, personnel, and financial) to meet with the specific requirements of accreditation standards.  Facilitates the procurement of additional licensures, accreditations and certifications across the health system in Florida.  Leads the review, response and correction of deficiencies identified by external accreditation and regulatory agencies.  Serves as a liaison, and represents the program on various hospital and community committees to enhance and foster understanding and influence the development of regulatory or accreditation standards. 
    • Data Collection - Uses proactive data analytics to identify potential regulatory and accreditation risks and collaborates with unit leadership to draft and implement effective and timely corrective action plans. Works in collaboration with leadership, clinical staff, and all members of the Quality and Safety team. Advises and facilitates policy drafts and revisions for NCH FL. 
    • Consulting and Liaison – Collaborates to pursue standard compliance throughout the complex network of disciplines that work in concert to provide high-quality children’s care.  Rounds in clinical areas to actively assess regulatory readiness. Serves as an internal resource for staff in all departments, interacts routinely with clinical associates in patient care settings, and acts as an extended liaison for other system entities. 
    • Research – Is involved, as appropriate, in research studies, analysis, and distribution of findings. 
    • Community and National Engagement in Children’s Health Care Systems - Participates in the development of accreditation and regulatory standards, as appropriate, for children’s health care  within professional collaborations at the community, and state levels.
    • Supervision of staff – is directly involved with management of all responsibilities related to oversight of staff members, as applicable.

     

    Position Requirements

    • Bachelors Degree required; knowledge of accreditation standards, survey readiness processes, and regulations application to hospitals, as well as primary/specialty care clinics and other healthcare settings
    • Certified Professional in Healthcare Quality preferred or obtained within 2 years
    • Minimum of three years experience required; experience in guiding a hospital/health system to achieving and maintain accreditation and ongoing compliance with appropriate local, state, and federal regulations.
  • 15 Days Ago

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Senior Manager, U.S. State Government Affairs -- East Region, U.S. Government Affairs
  • sapdev2.valhalla12.stage
  • Lake, FL FULL_TIME
  • Requisition ID: 289554 Work Area: Communication Expected Travel: 0 - 10% Career Status: Professional Employment Type: Regular Full Time COMPANY DESCRIPTION SAP started in 1972 as a team of five collea...
  • 11 Days Ago

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Regulatory Specialist
  • Actalent
  • Altamonte Springs, FL OTHER
  • Description:Responsible for assisting with the submission of research protocols and other required documents/components to the FDA for investigational new drug (IND)/investigational device exemption (...
  • 11 Days Ago

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Regulatory Specialist
  • Actalent
  • Orlando, FL OTHER
  • Great Opportunity to Join a Growing Team!Long-Term Opportunities!Competitive Pay Requirements:3 years of Clinical Research Regulatory experience REQUIREDOncology experience preferred Responsibilities:...
  • 14 Days Ago

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Regulatory Associate
  • CHARTER RESEARCH
  • The Villages, FL FULL_TIME
  • POSITION OVERVIEW The Regulatory Associate is responsible for processing regulatory packets and documents for each clinical trial protocol, maintaining regulatory files, and facilitating Institutional...
  • 23 Days Ago

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US E- Advisory – Manager - Contract Lifecycle Management (Icertis) - Regulatory &Legal Support
  • Deloitte US
  • Lake, FL FULL_TIME
  • Legal Business Services – Manager – Contract Lifecycle Management (Icertis)Deloitte Discovery’s Legal Business Services (LBS) teams provide a comprehensive suite of legal management consulting, inform...
  • 1 Month Ago

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0 Regulatory Affairs Manager jobs found in Orlando, FL area

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Senior Energy Transformation Consultant
  • Siemens Energy
  • Orlando, FL
  • *This position can be hired any location in the US. A Snapshot of your Day Are you passionate about driving the Energy T...
  • 4/19/2024 12:00:00 AM

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Metrics Specialist - REMOTE
  • Net Health
  • Orlando, FL
  • About Net Health Belong. Thrive. Make a Difference. Are you looking for a meaningful and satisfying career where you hav...
  • 4/18/2024 12:00:00 AM

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Closing Specialist
  • StraussGroup - Executive Search Consultants
  • Orlando, FL
  • The Closing Specialist is responsible for the closing documents, management of closing funds and maintaining file qualit...
  • 4/18/2024 12:00:00 AM

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Training Specialist (Senior Trainer) – EHS – Universal Epic Universe
  • Universal Orlando
  • Orlando, FL
  • Universal Orlando Resort believes in-person collaboration is key to our success. Many of our Team Members work in a hybr...
  • 4/18/2024 12:00:00 AM

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Health Operations Data Analyst (NOT REMOTE)
  • Watts Healthcare Corporation
  • Orlando, FL
  • With over 50 years of service, our goal is to improve the health of the community we serve by creating easier access to ...
  • 4/17/2024 12:00:00 AM

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Closing Specialist
  • Straussgroup - Executive Search Consultants
  • Orlando, FL
  • The Closing Specialist is responsible for the closing documents, management of closing funds and maintaining file qualit...
  • 4/16/2024 12:00:00 AM

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Metrics Specialist - REMOTE
  • Net Health
  • Orlando, FL
  • About Net Health Belong. Thrive. Make a Difference. Are you looking for a meaningful and satisfying career where you hav...
  • 4/16/2024 12:00:00 AM

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Health Operations Data Analyst (NOT REMOTE)
  • Watts Healthcare Corporation
  • Orlando, FL
  • With over 50 years of service, our goal is to improve the health of the community we serve by creating easier access to ...
  • 4/15/2024 12:00:00 AM

Orlando (/ɔːrˈlændoʊ/) is a city in the U.S. state of Florida and the county seat of Orange County. Located in Central Florida, it is the center of the Orlando metropolitan area, which had a population of 2,509,831, according to U.S. Census Bureau figures released in July 2017. These figures make it the 23rd-largest metropolitan area in the United States, the sixth-largest metropolitan area in the Southern United States, and the third-largest metropolitan area in Florida. As of 2015, Orlando had an estimated city-proper population of 280,257, making it the 73rd-largest city in the United State...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$130,734 to $184,407
Orlando, Florida area prices
were up 1.5% from a year ago

Regulatory Affairs Manager in Pittsfield, MA
The ideal candidate will have strong working knowledge of the agrochemical regulatory requirements.
December 24, 2019
Regulatory Affairs Manager in Stockton, CA
The world’s leading research-based pharmaceutical and healthcare companies is looking for a Regular Affairs Manager.
December 01, 2019
Regulatory Affairs Manager in Pierre, SD
Pharmaceutical companies, cosmetics manufacturers, food producers, and medical device suppliers hire regulatory affairs managers to make sure they adhere with all regulations.
February 01, 2020