Regulatory Affairs Specialist jobs in Fairbanks, AK

Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)

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Quality Specialist
  • InDyne, Inc.
  • Clear, AK FULL_TIME
  • InDyne is a full-service military, civilian and commercial operations company. Our Mission is to provide tailored cost effective, quality services and solutions. Our Vision is to exceed customer expectations by delivering results through agility, flexibility and responsiveness. Our Core Values include integrity, trust and loyalty.

    Note: The duties specified in this position description are not intended to be all-inclusive. Other reasonable and job-related duties may be assigned at the supervisor's and/or manager's discretion. Please use a bullet-point format in all areas.

    Job Summary: This position is located at Clear AFS, Alaska. The Quality Administrator will report directly to the Site Manager. The QC Administrator reports to the Site Manager with functionally independent reporting responsibility to the Quality Manager at the Program Management Office (PMO) in Colorado Springs. Assesses performance independent of the Site Manager but works closely with the Site Manager to ensure a viable, comprehensive quality program. Serves as a quality interface with Government Contracting Officer Representatives (CORs). Implements and directs the on-site quality management system to assess contractor performance in all areas of the contract. Executes the SSPARS Quality Manual and supporting procedures and instructions. Conducts site quality inspections/audits to assure conformance with Government and company quality standards and compliance with contract requirements. Coordinates quality issues and status with the Government site CORs as needed.

    Essential Duties and Responsibilities:

    • Primary responsibility is to implement and execute the SSPARS Quality Manual, and it's supporting procedures and instructions.
    • Establishes an effective working relationship with the Government CORs for quality improvement. Generates internal inspection/audit reports and responses and makes them readily available to the Government.
    • Applies knowledge of conventional fact-finding or inspection techniques and the skill to develop, analyze and evaluate facts relative to any unsatisfactory conditions or unfavorable trends and to prepare documented reports of findings.
    • Ensures adherence to directives, operating instructions, and technical publications applicable to the performance of contract requirements at the site.
    • Reads, interprets and develops in-depth checklists from the Performance Work Statement (PWS) and its supporting Air Force Documents, Technical Orders, Federal, State and local regulations.
    • Monitors periodic Self-Inspections from work-centers and associated CE Maintenance Action Sheets and operating instructions as applicable.
    • Performs quality inspections/audits of each work center and documents performance.
    • Conducts additional inspections or investigations as requested by the Contract Site Manager and PMO Quality Manager.
    • Ensures all inspection reports of Government and contractor identified discrepancies clearly state corrective action and addresses action taken to preclude recurrence.
    • Ensures any discrepancies remaining open (awaiting parts/materials, awaiting scheduled downtime, etc.) have an estimated completion date indicating the response and tracks them until closed.
    • Performs follow-up inspections as needed to verify discrepancies have been corrected.
    • Generates the monthly Quality Status Report (D002) and provides to the Contract Site Manager and Quality Manager and delivers as required.
    • Manages the site quality cross feed program to ensure each work center receives cross feeds generated by the other sites and uses them to ensure similar discrepancies or deficiencies do not exist at their particular site.
    • Follows up to ensure similar deficiencies do not exist and the work center has used the cross-feed report.
    • Provides cross feed results to the PMO Quality Manager.
    • Uses the SSPARS Quality Management SharePoint website to reference the quality program documentation to include processes, instructions, forms, cross feeds, management reviews etc.
    • Serves as the lead site responsible for formatting, maintenance and upkeep of all Audit Checklists and forwards revised checklists and Master Checklist Index to the other 4 SSPARS sites immediately following approval of PMO Quality Manager.

    Secondary Duty Responsibilities:

    • Serve on the Air Force Exercise Evaluation Team (EET) to evaluate response to problem scenarios in disaster management, environmental, safety and civil engineering. As an exempt employee, will be required to perform the function of duty manager as scheduled.

    Educational/Training Requirements:

    • A two-year community college technical degree is desirable.
    • Additional three years' experience in related quality programs may be acceptable in lieu of a degree.
    • Must be knowledgeable of Air Force inspection processes.
    • The applicant selected will be subject to a government security investigation and must meet eligibility requirements for access to classification information.

    Required Skills/Experience: (List any specific skills required and amount of experience necessary to perform job. i.e. supervisory experience, certification/license, driver's license, security clearance)

    • Four years' related experience in quality control/quality assurance administration with a background in one or more of the following: communications-electronics, civil engineering, Air Force Industrial Security program or Air Force supply system.
    • Experience using the ISO 9001:2008 quality standard and using computer databases would be an asset.

    Supervision:

    • Works under the general supervision of the Site Manager.

    Work Environment:

    • Exerts limited physical energy. May have to handle 20-30-pound loads on occasion.
    • Computing center environment. May work extended hours or weekends. May travel overnight or on weekends. Support the system via "on call" when outside of normal working hours.

    Physical Demands:

    • Must be able to correctly lift 50 Lbs.
    • Must be able to travel.

    ****InDyne is an Affirmative Action/Equal Opportunity Employer. Women, minorities, veterans, and individuals with disabilities are encouraged to apply. Any person with a disability needing special accommodations to the application process please call our Human Resources department


    InDyne is an Affirmative Action/Equal Opportunity Employer. Women, minorities, veterans, and individuals with disabilities are encouraged to apply. Any person with a disability needing special accommodations to the application process please call Human Resources.

     

  • 18 Days Ago

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MSO Specialist
  • Arctic Slope Native Association LTD
  • Barrow, AK FULL_TIME
  • Brief Summary: Perform a variety of administrative duties for the department staff and assist with matters related to credentialing of the hospital staff. Qualifications: To perform this job successfu...
  • 20 Days Ago

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System specialist
  • UIC
  • Point Lay, AK FULL_TIME
  • Overview UIC Municipal Services is based in Utqiagvik. Our mission is to help the North Slope Borough achieve their goals to sustain and improve the quality of life for the North Slope Borough residen...
  • 20 Days Ago

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HSE Specialist
  • Delta Constructors
  • Prudhoe Bay, AK FULL_TIME
  • Essential Job Functions: Inspects jobsites for potentially hazardous conditions, safe work practices, behaviors, health and environmental concerns and performs safety audits. Provides guidance and sup...
  • 21 Days Ago

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REALTY SPECIALIST
  • US Pacific Air Forces
  • Eielson AFB, AK FULL_TIME
  • Duties Completes studies on requirements for in/out grants, and withdrawn public lands. Acts as the program manager for land, real estate transactions, leased space, and/or facility space to support t...
  • 21 Days Ago

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Communications Specialist
  • Fairbanks North Star Borough School District
  • Fairbanks, AK FULL_TIME
  • JobID: 9822 Position Type: Administrative Services/Communications Date Posted: 6/7/2022 Location: Administration Center Date Available: ASAP Note: Unless otherwise stated, all vacancies with a specifi...
  • 22 Days Ago

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0 Regulatory Affairs Specialist jobs found in Fairbanks, AK area

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Medical Assistant (MA) - TVC Family Medicine Outpatient Clinic
  • Foundation Health, LLC
  • Fairbanks, AK
  • Overview: Medical Assistant professional. This position is responsible for assisting clinicians and nursing staff in pro...
  • 4/26/2024 12:00:00 AM

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Certified Nursing Assistant (CNA) - Intensive Care Unit
  • Foundation Health, LLC
  • Fairbanks, AK
  • Overview: This position provides routine patient care to promote patient comfort and contribute to the overall patient p...
  • 4/26/2024 12:00:00 AM

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Supervisory Legal Admin Specialist (Estate & Gift Tax) 12 month register Direct Hire Amended
  • Department Of The Treasury
  • Fairbanks, AK
  • Duties WHAT IS THE SMALL BUSINESS SELF EMPLOYED (SBSE)DIVISION? A description of the business units can be found at: htt...
  • 4/26/2024 12:00:00 AM

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Legal Admin Specialist (Estate & Gift Tax) (Estate Tax Technical Advisor) (TEMP NTE 1 YR MBE, MBP)
  • Department Of The Treasury
  • Fairbanks, AK
  • Duties WHAT IS THE SMALL BUSINESS SELF EMPLOYED (SBSE)DIVISION? A description of the business units can be found at: htt...
  • 4/26/2024 12:00:00 AM

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Sterile Processing Technician Apprentice Program
  • Foundation Health, LLC
  • Fairbanks, AK
  • Overview: The Sterile Processing Tech Apprentice Program job is a trainee position subject to the terms and conditions o...
  • 4/25/2024 12:00:00 AM

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Certified Nursing Assistant (CNA) - Medical/Surgical 3West
  • Foundation Health, LLC
  • Fairbanks, AK
  • Overview: This position provides routine patient care to promote patient comfort and contribute to the overall patient p...
  • 4/24/2024 12:00:00 AM

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Registration Representative I - Hospital Admitting
  • Foundation Health, LLC
  • Fairbanks, AK
  • Overview: This position greets patients and families, conducts patient registration, and obtains financial reimbursement...
  • 4/23/2024 12:00:00 AM

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Registration & Scheduling Representative I - Radiation Oncology Clinic
  • Foundation Health, LLC
  • Fairbanks, AK
  • Overview: This position greets patients and families, conducts patient registration, and obtains financial reimbursement...
  • 4/22/2024 12:00:00 AM

Fairbanks (Tanana: Tanan) is a home rule city and the borough seat of the Fairbanks North Star Borough in the U.S. state of Alaska. Fairbanks is the largest city in the Interior region of Alaska. 2016 estimates put the population of the city proper at 32,751, and the population of the Fairbanks North Star Borough at 97,121, making it the second most populous metropolitan area in Alaska (after Anchorage). The Metropolitan Statistical Area encompasses all of the Fairbanks North Star Borough and is the northernmost Metropolitan Statistical Area in the United States, located 196 driving miles (or ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$84,309 to $112,987
Fairbanks, Alaska area prices
were up 2.8% from a year ago

Regulatory Affairs Specialist in Long Beach, CA
In addition to keeping informed of licensing and legal documentation requirements, a regulatory affairs specialist is involved in less-visible yet vastly important industry issues, such as packaging and labeling.
December 16, 2019
Regulatory Affairs Specialist in Albuquerque, NM
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
February 20, 2020
Regulatory Affairs Specialist in Petaluma, CA
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020