Regulatory Affairs Specialist jobs in Maryland

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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Regulatory Affairs Specialist
  • MillenniumSoft Inc
  • Sparks, MD FULL_TIME
  • Position: Regulatory Affairs Specialist

    Location: Sparks, MD

    Duration: 3 Months Contract

    Total Hours/week: 40.00

    1st shift

    The Individual Will Work With Global Colleagues To Support Korea, China, And/Or Other Countries As They Fulfill Requirements To Register Products

    Regulatory Affairs is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval.

    • Demonstrates working knowledge of healthcare-related regulations
    • Demonstrates in-depth knowledge of preparing a submission
    • Demonstrates in-depth knowledge of industry and competitive products
    • Applies relevant regulations and statutes to further product submissions of basic to medium complexity
    • Contributes to the strategic direction of regulatory pathway development
    • Refines and conforms the preliminary data used in the submission process
    • Translates technical data and descriptions into reviewer-friendly content
    • Helps to ensure that the appropriate regulatory requirements for the submission are met
    • Interacts with regulatory body to help further product approvals or clearance
    • Has in-depth experience, knowledge and skills in own job family Applies knowledge and skills to a wide range of standard and non-standard situations
    • Works independently with minimal guidance Usually determines own work priorities Acts as a resource for colleagues with less experience
  • 10 Days Ago

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Editor, Publishing
  • Regulatory Affairs Professionals Society
  • Rockville, MD FULL_TIME
  • Location: Rockville, MD (Hybrid or Remote) Key Skills: Substantive editing, copyediting, editorial project management Experience: 5-7 years editorial experience Reports to: Director of Publications *A...
  • 1 Month Ago

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Regulatory Affairs Specialist (Research Facilities)
  • USAJOBS
  • Montgomery, MD FULL_TIME
  • DutiesAs a GS-0601 Regulatory Affairs Specialist In The Clinical Center, Your Duties May Include But Are Not Limited To The Following:Direct responsibility using knowledge of regulatory statutes and g...
  • 6 Days Ago

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Regulatory Affairs Specialist, Medical Device
  • Katalyst Healthcares & Life Sciences
  • Baltimore, MD FULL_TIME
  • Company DescriptionKatalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.We have ...
  • 1 Day Ago

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Public Affairs Officer
  • US Nuclear Regulatory Commission
  • Rockville, MD FULL_TIME
  • Duties The successful candidate will perform the full range of public affairs duties. Such duties include but are not limited to: Assist in the administration of stakeholder outreach that contributes ...
  • 2 Months Ago

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Emergency Preparedness Specialist
  • US Nuclear Regulatory Commission
  • Rockville, MD FULL_TIME
  • Duties The successful candidate will perform the full range of Emergency Preparedness Specialist duties. Such duties include but are not limited to: Assisting in the reviews of appropriate sections of...
  • 10 Days Ago

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Regulatory Affairs Specialist
  • GForce Life Sciences
  • Santa Clara, CA
  • Regulatory Affairs Specialist II – Santa Clara, CA Must be able to work on a W2 Job Summary We're looking for a Regulato...
  • 6/11/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Experis
  • Maplewood, MN
  • Our client, is seeking a Regulatory Specialist to join their team. As a Regulatory Specialist, you will lead/ coordinate...
  • 6/11/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Planet Pharma
  • Immediate need for Regulatory Affairs Specialist with a Clinical Research Organization in Raleigh. Hybrid position - wil...
  • 6/10/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Astrix
  • Fort Worth, TX
  • Exciting 2 year development opportunity to work for a global leader dedicated to helping people see brilliantly. The lar...
  • 6/10/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Highridge Medical
  • Westminster, CO
  • Job Summary: HIGHRIDGE creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation...
  • 6/9/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • CM Medical Recruitment
  • CM Medical is seeking an experienced regulatory professional to join a fast growing team in the EP/CRM device space. In ...
  • 6/8/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Baylor College of Medicine
  • Texas City, TX
  • Division: Office of Research Work Arrangement: Onsite only Location: Texas Medical Center, Houston, TX Salary Range: $54...
  • 6/8/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Net2Source Inc.
  • Palo Alto, CA
  • Job Title: Regulatory Affairs Professional 4 Duration: 12 months (Possible Extension ) Location: Palo Alto CA 94304 (Hyb...
  • 6/7/2024 12:00:00 AM

Maryland (US: /ˈmɛrələnd/ (listen) MERR-əl-ənd) is a state in the Mid-Atlantic region of the United States, bordering Virginia, West Virginia, and the District of Columbia to its south and west; Pennsylvania to its north; and Delaware to its east. The state's largest city is Baltimore, and its capital is Annapolis. Among its occasional nicknames are Old Line State, the Free State, and the Chesapeake Bay State. It is named after the English queen Henrietta Maria, known in England as Queen Mary. Sixteen of Maryland's twenty-three counties border the tidal waters of the Chesapeake Bay estuary and...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$78,712 to $105,483

Regulatory Affairs Specialist in Petaluma, CA
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
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
Regulatory Affairs Specialist in Boulder, CO
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
February 03, 2020
Regulatory Affairs Specialist in Concord, NH
Are you working as a Regulatory Affairs Specialist? Help us rate Regulatory Affairs Specialist as a Career.
December 31, 2019