Drug Safety/Medical Information Specialist jobs in Utah

Drug Safety/Medical Information Specialist is responsible for collecting, monitoring, processing, and distributing adverse event reports and information queries for investigational and marketed products. Reviews safety and medical information for the assigned products, including safety components of protocols and studies for assigned drugs. Being a Drug Safety/Medical Information Specialist may require a bachelor's degree in area of specialty. Typically reports to a supervisor or manager. To be a Drug Safety/Medical Information Specialist typically requires 0-2 years of related experience. Works on projects/matters of limited complexity in a support role. Work is closely managed. (Copyright 2024 Salary.com)

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Medical Device & Drug Compliance Specialist
  • Fresenius Medical Care
  • Ogden, UT FULL_TIME
  • Position in Ogden, Utah.

    PRINCIPAL DUTIES AND RESPONSIBILITIES:  

    • Ensure that all design control deliverables comply with applicable regulatory requirements and design controls SOPs
    • Prepare together with Project Manager’s the design and development documentation for project and for design control activities.
    • Support Product Center/Project Manager to get part needed to Medical Device Compliance and Regulatory Affairs to complete Technical Dossier/Registration dossier.
    • Provide Training on design & development relevant quality requirements.
    • Provide input to design and development and design changes and take accountability for quality compliance as a member of the cross-functional project team representing Product Center for Design Quality part.
    • Review and approve all product development and Design Change projects in compliance with Fresenius Quality Management System / SOP requirements by:
      • Preparation / Review and approval of applicable design control documentation
      • Design Review, Phase Exit Review and Milestone approval
      • Preparation of applicable document and sample review of design control documentation during project execution
    • Act as Quality Approver for Design and Development related NC/CAPA
    • Create and monitor compliance metrics of design controls in development and change management activities.
    • Audit support of design and development sessions
    • Providing management quality review inputs for Design and development
    • Support Product Center in writing MDR Technical Documentation and related documentation.

    EXPERIENCE AND REQUIRED SKILLS:

    • Degree in Technical/Engineering and/or Scientific background, in lieu of degree additional years of relevant experience and/or education may be considered.
    • Minimum 2 years in Regulatory Affairs or similar in pharmaceutical/medical field
    • Strong relationship building with international colleagues and superiors.
    • High engagement on achieving the targets and the objectives of the position, proactive and solution-oriented approach towards problems, ability to work cross functional with all levels of employees.
    • Organizational capacity and analytical ability
    • Independent working structure
    • Autonomy in decision making.
    • Advanced knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR 745/2017, MDSAP etc.)
    • Advanced knowledge of applicable quality management and of risk management standards (e. g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CFR, etc.)
    • Knowledge of internal and external processes and structures and of the corporate Quality Management requirements
    • Knowledge of CAPA methodology
    • Knowledge in statistical methods
    • Support Regulatory Affairs 
    • Capability to relate to all corporate functions (at corporate level)
    • Interface to keep up to date the technical documentation relevant for regulatory purposes (e.g. usability report, interface verification test report, biocompatibility, labelling etc.)
  • 1 Day Ago

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Medical Device & Drug Compliance Specialist
  • Fresenius Medical Care
  • Ogden, UT FULL_TIME
  • Position in Ogden, Utah.PRINCIPAL DUTIES AND RESPONSIBILITIES: Ensure that all design control deliverables comply with applicable regulatory requirements and design controls SOPsPrepare together with ...
  • 4 Days Ago

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Davis Food and Drug Open Application
  • Davis Food and Drug
  • Roosevelt, UT FULL_TIME
  • Davis Food and Drug - Open ApplicationThank you for your interest in Davis Food and Drug. We do not currently have an open position; however, we would love to accept your application. We will use the ...
  • 9 Days Ago

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Software Development Specialist
  • USA 3M Health Information Systems, Inc.
  • US, UT FULL_TIME
  • Job Description: Software Development Specialist 3M is establishing two industry-leading companies, creating value through the spin-off of its Health Care business, while 3M will continue to be a glob...
  • 1 Month Ago

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Clinical Applications Specialist, MIC, NICU
  • MS0059 GE Medical Systems Information Technologies, Inc.
  • Phoenix, UT FULL_TIME
  • Job Description Summary Working within the MIC NICU national team, provides expertise in analyzing technical learning needs for the services function, then designs and delivers training solutions. Imp...
  • 1 Month Ago

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Health Information Specialist I
  • Datavant
  • American Fork, UT OTHER
  • Overview Who we are... Datavant protects, connects, and delivers the world’s health data to power better decisions and advance human health. We are a data logistics company for healthcare whose produc...
  • 19 Days Ago

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Broadband Specialist I
  • Mediacom Communications Corporation
  • Brookings, SD
  • Position: Broadband Specialist I Who we are: Since 1995, Mediacom Communications has become a coast-to-coast presence wi...
  • 3/28/2024 12:00:00 AM

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Broadband Specialist I
  • Mediacom Communications Corporation
  • Chatfield, MN
  • Position: Broadband Specialist I Who we are: Since 1995, Mediacom Communications has become a coast-to-coast presence wi...
  • 3/28/2024 12:00:00 AM

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Broadband Specialist I
  • Mediacom Communications Corporation
  • Creston, IA
  • Position: Broadband Specialist I Who we are: Since 1995, Mediacom Communications has become a coast-to-coast presence wi...
  • 3/28/2024 12:00:00 AM

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Broadband Specialist I
  • Mediacom Communications Corporation
  • Benson, MN
  • Position: Broadband Specialist I Currently seeking applicants from Clinton, Graceville, Wheaton, and Morris. Who we are:...
  • 3/28/2024 12:00:00 AM

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Broadband Specialist I- Jackson, Mt. Vernon, Leroy, Grove Hill areas
  • Mediacom Communications Corporation
  • Thomasville, AL
  • Position: Broadband Specialist I Who we are: Since 1995, Mediacom Communications has become a coast-to-coast presence wi...
  • 3/28/2024 12:00:00 AM

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Brookstone Tech Associate
  • Hudson Group
  • Chicago, IL
  • WE ARE OFFERING A $300 HIRING BONUS FOR JOINING OUR TEAM! Grow With Us! Hudson is North America's leading travel retaile...
  • 3/28/2024 12:00:00 AM

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Medical Information Specialist - Cardiovascular
  • The Carolan Group
  • Boston, MA
  • Job Title: Medical Information Specialist (Cardiovascular) Company Overview: Join a dynamic and innovative biotech compa...
  • 3/27/2024 12:00:00 AM

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Laboratory Diagnostics Medical Information Specialist -Remote within the US
  • Siemens Corporation
  • Newark, DE
  • Do you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more pe...
  • 3/26/2024 12:00:00 AM

Utah is known for its natural diversity and is home to features ranging from arid deserts with sand dunes to thriving pine forests in mountain valleys. It is a rugged and geographically diverse state that is at the convergence of three distinct geological regions: the Rocky Mountains, the Great Basin, and the Colorado Plateau. Utah is one of the Four Corners states, and is bordered by Idaho in the north, Wyoming in the north and east; by Colorado in the east; at a single point by New Mexico to the southeast; by Arizona in the south; and by Nevada in the west. It covers an area of 84,899 sq mi ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Drug Safety/Medical Information Specialist jobs
$62,302 to $77,461