Regulatory Affairs Director jobs in Alaska

Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes 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 Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Quality improvement
  • Regulatory Affairs Professionals Society
  • Fairbanks, AK FULL_TIME
  • Details

    Posted : 05-Jun-24

    Location : Fairbanks, Alaska

    Salary : Open

    Categories :

    Quality / Risk Management

    Internal Number : 14427

    Overview

    This position provides ongoing assessment of performance, facilitates prioritization of improvement activities, oversees performance improvement projects and ensures successful clinical project implementation at operating entities.

    The position works closely with both system and operating entity initiatives. All work processed by the incumbent is considered confidential and protected from discovery, pursuant to state statutes.

    About Fairbanks Memorial Hospital

    Fairbanks Memorial Hospital is a non-profit facility owned by the Greater Fairbanks Community Hospital Foundation. A Joint Commission-accredited facility with 152 licensed beds, Fairbanks Memorial Hospital is the primary referral center for residents of Alaska's interior with a strong patient-to-nurse ratio and Shared Leadership Infrastructure.

    In addition to our exceptional clinical environment, our location offers incomparable lifestyle rewards away from work. In Fairbanks, small-town living, spectacular natural beauty and endless recreation combine to create a one-of-a-kind place to live, work and play.

    Responsibilities

    • Supports implementation of clinical practices. May support and facilitate implementation and performance improvement activities related to or resulting from patient safety, harm reduction, clinical performance, peer review, and compliance with the requirements of regulatory and accrediting agencies such as TJC, CMS, Quality Improvement Organization and DHS.
    • Provides ongoing assessment of performance, analyzes clinical outcome data, and identifies performance improvement opportunities or trends.

    Conducts high level assessments, gathers information and collaborates with the appropriate process owner(s) to identify opportunities for improvement.

    Analyzes data for administrative and clinical decision making.

    • Facilitates prioritization of improvement activities with system and facility leadership.
    • Supports development of annual quality plans with service line / process owners.
    • Initiates and oversees performance improvement projects in collaboration with project lead. Serves as a resource and / or facilitates improvement teams to plan, implement, and coordinate entity activities to maximize clinical and operational outcomes.

    Participates on improvement teams, guiding / coaching them on the system defined improvement process.

    • Serves as a resource for assessment of clinical performance and performance improvement methodologies throughout the facility and system.
    • Maintains clinical performance assessment, performance improvement, change management and project facilitation expertise through independent study as well as attending education workshops, reviewing professional publications, establishing personal networks, and participating in professional societies.

    Provides all customers of Foundation Health with an excellent service experience by consistently demonstrating our core and leader behaviors each and every day.

    Qualifications

    Requires Bachelor's degree or equivalent in nursing or other healthcare related field and either an RN license in state worked OR a clinical background with current license / certification or equivalent experience.

    Requires a proficiency level typically attained with 5 years acute care clinical experience.

    Requires ability to perform complex statistical analysis and highly developed problem solving skills. Requires the ability to manage programs and projects.

    Requires demonstrated excellence in interpersonal and written communication skills.

    PREFERRED QUALIFICATIONS

    Registered Nurse (RN) license preferred. Certified Professional in Healthcare Quality (CPHQ) certification is preferred.

    Experience with process improvement, regulatory / accreditation programs, data management, and analysis including graphic development and presentations is highly desirable.

    Additional related education and / or experience preferred.

    Foundation Health Partners is an EEO / AAP employer; qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.

    Last updated : 2024-06-05

  • 5 Days Ago

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Regulatory Affairs Associate
  • Dorsey & Whitney LLP
  • Anchorage, AK FULL_TIME
  • Dorsey is seeking a Regulatory Affairs Associate with four to six years of experience to join our Anchorage office. This associate will have the opportunity to work on a wide variety of issues and mat...
  • 2 Days Ago

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Regulatory Affairs Associate (#856)
  • Dorsey & Whitney LLP
  • Anchorage, AK FULL_TIME
  • Dorsey and Whitney LLP is seeking a Regulatory Affairs Associate with four to six years of experience to join the Anchorage office. This associate will have the opportunity to work on a wide variety o...
  • 2 Months Ago

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Supervisory Psychologist (Vet Center Director)
  • U.S. Department of Veterans Affairs
  • Wasilla, AK FULL_TIME
  • SummaryThe incumbent serves as Supervisory Psychologist (Vet Center Director) on the multidisciplinary team that is located in a community-based Vet Center that provides Veterans, service members, and...
  • 18 Days Ago

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Supervisory Social Worker-Whole Health Clinical Director
  • US Department of Veterans Affairs
  • Anchorage, AK FULL_TIME
  • As Whole Health Clinical Director/Supervisory Social Worker he/she has broad program management responsibilities. Serves as a consultant with facility health care staff in evaluating health care deliv...
  • 29 Days Ago

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Director of Government Affairs
  • Aleut Corporation
  • Anchorage, AK FULL_TIME
  • DIRECTOR OF GOVERNMENT AFFAIRS Reports to: Vice President of Regional Affairs Status: Regular, Full-time, Exempt Location: Anchorage, AK JOB SUMMARY: The Director of Government Affairs will be respons...
  • 2 Days Ago

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Head of Regulatory Affairs
  • Exegenesis Bio Inc
  • Ambler, PA
  • Job Description Job Description Job Title: Head of Regulatory Science Reports to (Title): CEO Location: Remote, US Exemp...
  • 6/11/2024 12:00:00 AM

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Head of Regulatory Affairs
  • EPM Scientific
  • Our client, a clinical stage biotech company, is seeking an experienced and dynamic Head of Regulatory Affairs to join t...
  • 6/10/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Verano
  • Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
  • 6/10/2024 12:00:00 AM

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Head of Regulatory Affairs
  • Hiring Now!
  • West Hills, CA
  • HELP US BRING THE GIFT OF HEALTH TO LIFE.Working at Pharmavite is an experience like no other. With a focus on complete ...
  • 6/8/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Catalyst Life Sciences
  • Our client is actively looking for a (Senior) Director of RA/QA to join their growing team. This is a hybrid position su...
  • 6/8/2024 12:00:00 AM

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Head of Regulatory Affairs
  • Kaye/Bassman International
  • San Diego, CA
  • Position Title: Head of Regulatory Affairs Location: Southern California Company Overview: We are partnered with a cutti...
  • 6/7/2024 12:00:00 AM

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Sr. Director of Regulatory Affairs - Oncology
  • Mantell Associates
  • Boston, MA
  • Mantell Associates is currently partnered with an innovative Biotech company, developing much-needed therapies for peopl...
  • 6/7/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Verano
  • Chicago, IL
  • Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
  • 6/7/2024 12:00:00 AM

Alaska is the northernmost and westernmost state in the United States and has the most easterly longitude in the United States because the Aleutian Islands extend into the Eastern Hemisphere. Alaska is the only non-contiguous U.S. state on continental North America; about 500 miles (800 km) of British Columbia (Canada) separates Alaska from Washington. It is technically part of the continental U.S., but is sometimes not included in colloquial use; Alaska is not part of the contiguous U.S., often called "the Lower 48". The capital city, Juneau, is situated on the mainland of the North American ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$185,018 to $263,512

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The regulatory affairs director might engage in reading and responding to letters from the FDA, including any “warning letters” about unapproved activities or products.
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The office of regulatory affairs is a dynamic work environment where communication with employees at all levels within the organization is extremely important.
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