Regulatory Affairs Manager jobs in Maine

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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Program Manager- Accreditation & Regulatory Affairs
  • MaineHealth
  • Portland, ME FULL_TIME
  • Summary

    • **RN or clinical experience preferred. 
    • Primarily responsible for all operational aspects of the assigned program including development, implementation, maintenance, and evaluation.  Works with other teams and ensures that all tasks are completed in a timely manner and in coordination with the work teams.  Oversees the work of additional staff, if applicable.
    •  
    • Required Minimum Knowledge, Skills, and Abilities (KSAs)
      • Education: Bachelor's degree in health care or related field required. Master's degree preferred. 
      • License/Certifications: Licensure may be preferred or required.
      • Experience: Knowledge of project management, administrative practices and hospital/healthcare systems normally acquired during 3 to 5 years of related work experience.
      • A high level of analytical skills necessary to assist in the development and implementation of new systems, techniques, to assess patient care and business workflow and/or procedures, to help determine departmental needs, to support improvements in departmental functioning, and to prepare special and recurring reports or analysis. Ability to use a wide array of evaluative and analytic techniques, including quantitative and qualitative methods.
      • Knowledge of healthcare systems, including but not limited to the organization and financing of health systems and healthcare, managed care systems, health policy, process improvement, and public health principles.
      • Knowledge of, and preferably experience in, clinical process improvement literature, techniques, methods, and facilitation.
      • Demonstrated ability to communicate effectively in writing and in public presentations; ability to write papers, reports and proposals for a variety of audiences.
      • Excellent organizational skills necessary for project planning, definition, implementation, and evaluation of effectiveness. Ability to lead work teams.
      • Ability to work both independently and to collaborate with teams of individuals in diverse settings.
      • Knowledge of relevant practice in medical care, patient care, and support systems. Ability to research and synthesize medical and health services literature.

    Additional Information

    MaineHealth is a health system whose members and affiliates include hospitals, physician practices, long-term care facilities, home care agencies, and support services. Learn more about this system at www.mainehealth.org
  • 10 Days Ago

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Regulatory Affairs
  • Maine Molecular Quality Controls, Inc
  • Saco, ME FULL_TIME
  • Position Title: Quality Assurance/Regulatory Affairs Specialist II Employer: Maine Molecular Quality Controls, Inc. (MMQCI) designs, develops, manufactures, and markets unique quality control products...
  • 2 Months Ago

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Regulatory Affairs Program Manager - Quality and Safety
  • MaineHealth
  • South Portland, ME FULL_TIME
  • Summary *** Outpatient/Ambulatory experience is highly preferred *** Position Summary Primarily responsible for all operational aspects of the assigned program including development, implementation, m...
  • 21 Days Ago

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Program Manager- Accreditation & Regulatory Affairs Interested in working for MaineHealth
  • MaineHealth
  • Portland, ME OTHER
  • Summary **RN or clinical experience preferred. Primarily responsible for all operational aspects of the assigned program including development, implementation, maintenance, and evaluation. Works with ...
  • 8 Days Ago

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Program Manager - Accreditation and Regulatory Affairs Southern Region Supervisor
  • MaineHealth
  • Portland, ME FULL_TIME
  • Summary *** Accreditation and regulatory experience preferred. HACP preferred. *** Position Summary Primarily responsible for all operational aspects of the assigned program including development, imp...
  • 12 Days Ago

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Regulatory Affairs Program Manager - Quality and Safety Interested in working for MaineHealth
  • MaineHealth
  • Portland, ME OTHER
  • Summary *** Outpatient/Ambulatory experience is highly preferred *** Position Summary Primarily responsible for all operational aspects of the assigned program including development, implementation, m...
  • 24 Days Ago

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Regulatory Affairs Manager
  • Dental Technologies Inc
  • Lincolnwood, IL
  • Job Description Job Description Job Title: Regulatory Affairs Manager Department: Quality Assurance Reports To: Vice Pre...
  • 6/11/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Catalyst Life Sciences
  • Chicago, IL
  • Opportunity to join a global diagnostics company at their HQ just outside of Chicago, focused on the strategy for existi...
  • 6/10/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Blueroot Health™
  • PURPOSE STATEMENT: This position will be responsible for managing and coordinating implementation of regulatory requirem...
  • 6/10/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Lumicity
  • This opportunity is with a company revolutionizing the medical device industry with its cutting-edge technologies and co...
  • 6/9/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Tandym Group
  • Stamford, CT
  • Top hospital in Fairfield county, CT, just over the border from Westchester county NY, is seeking an experienced Regulat...
  • 6/8/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Mastech Digital
  • Oakland, CA
  • Position: HIM Director-Regulatory Affairs Manager Location: Oakland CA USA 94612 (5 days onsite) Duration: 12+ Months (P...
  • 6/7/2024 12:00:00 AM

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Regulatory Affairs Manager
  • SS White Dental
  • Lakewood, NJ
  • SS White Dental is seeking a Senior Regulatory Affairs Manager to support our Regulatory team. Candidates should have a ...
  • 6/7/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Procter & Gamble
  • Reading, England
  • Job Location Reading Job Description P&G is a leading global consumer goods company whose winning brands are Procter & G...
  • 5/22/2024 12:00:00 AM

To the south and east is the Atlantic Ocean and to the north and northeast is New Brunswick, a province of Canada. The Canadian province of Quebec is to the northwest. Maine is both the northernmost state in New England and the largest, accounting for almost half of the region's entire land area. Maine is the only state in the continental US to border only one other American state (New Hampshire to the South and West). Maine is the easternmost state in the United States in both its extreme points and its geographic center. The town of Lubec is the easternmost organized settlement in the United...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$134,729 to $190,037

Regulatory Affairs Manager in Wichita Falls, TX
Other names for this job might include Clinical Trials Systems Administrator, Global Regulatory Affairs Manager, Regulatory Administrator, Regulatory Affairs Director, Regulatory Affairs Manager, Regulatory Affairs Portfolio Leader, Regulatory Consultant, Regulatory Leader, Regulatory Process Manager, Regulatory Product Manager.
January 17, 2020
Regulatory Affairs Manager in Baltimore, MD
Lead strategic contributions and initiatives to develop regulatory services and improve current processes and procedures.
January 18, 2020
Regulatory Affairs Manager in Fort Lauderdale, FL
Regulatory Domain Support for business development, including solutioning and developing innovative solutions, creation of materials for and participation in sales pursuits, key client meetings, bid defences for RFIs and RFPs.
December 04, 2019